{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 1909496 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "LOT #1, ROAD #3, KM 79.7", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "RI", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "HUMACAO", "manufacturer_contact_address_1": "100 CROSSINGS BLVD.", "manufacturer_contact_pcity": "40182584", "event_type": "Injury", "report_number": "1213643-2020-03974", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K122436", "date_of_event": "20190523", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "02886", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4018258495", "noe_summarized": "1", "manufacturer_contact_l_name": "TOPOULOS", "source_type": [ "Other", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "00791", "manufacturer_g1_state": "PR", "reporter_country_code": "US", "manufacturer_contact_area_code": "401", "date_added": "20200427", "manufacturer_contact_f_name": "ANDREW", "device_date_of_manufacturer": "20170115", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "463498", "implant_date_year": "2017", "date_removed_year": "2019", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "VENTRALIGHT ST W/ ECHO", "generic_name": "SURGICAL MESH", "manufacturer_d_name": "DAVOL INC., SUB. 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BARD, INC. -1213643", "manufacturer_d_address_1": "100 CROSSINGS BLVD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "WARWICK", "manufacturer_d_state": "RI", "manufacturer_d_zip_code": "02886", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "02886", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20190128", "model_number": "NA", "catalog_number": "5955810", "lot_number": "HUBN1249", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00801741031786", "udi_public": "(01)00801741031786(17)190128(10)HUBN1249", "openfda": { "registration_number": [ "1213643" ], "fei_number": [ "1213643" ], "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Defective Device", "Patient-Device Incompatibility", "Insufficient Device Problem Information", "Defective Device", "Patient-Device Incompatibility", "Insufficient Device Problem Information" ], "reporter_state_code": "RI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/20/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250826", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4018", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability", " R", " L" ], "patient_age": "54 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Adhesion(s)", "Pain", "Injury", "Disability", "Bowel Perforation", "Abscess", "Adhesion(s)", "Pain", "Injury", "Disability", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20250528", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARWICK", "mdr_report_key": "10000311", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200414", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "00791", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BARD SHANNON LIMITED 3005636544", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189732453", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES SURGICAL INTERVENTION AND GENERAL ALLEGATIONS FOR \"PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT\"; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALIGHT ST MESH (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALIGHT ST MESH (DEVICE #1). SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED." }, { "mdr_text_key": "189732454", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL VENTRALIGHT ST MESHES ON (B)(6) 2014 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. IT IS ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERIES ON (B)(6) 2017 AND (B)(6) 2019 DUE TO THE HERNIA MESH DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.\" IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE." }, { "mdr_text_key": "371462984", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL VENTRALIGHT ST MESHES ON (B)(6) 2014 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. IT IS ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERIES ON (B)(6) 2017 AND (B)(6) 2019 DUE TO THE HERNIA MESH DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.\" IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #1). PER OP NOTES, ¿A VENTRALIGHT ST MESH USING ECHO PS (DEVICE #1) WAS PLACED IN THE ANTERIOR ABDOMINAL WALL USING TACKERS.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2 & #3). PER OP NOTES, ¿THERE WERE ADHESIONS EXTENDING FROM THE MID TO LOWER ABDOMEN. THERE WAS AN EDGE OF THE OLD MESH (DEVICE #1) THAT HAD CURLED OVER. TWO VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2 & #3) WERE PLACED IN THE ABDOMEN TO COVER THE OLD MESH.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS WITH PERFORATED CECUM THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1, #2 & #3). PER OP NOTES, ¿A MODERATE AMOUNT OF PURULENT FLUID WAS NOTED. PERFORMED ADHESIOLYSIS. IDENTIFIED THE PERFORATION OF THE CECUM AND WAS TAKEN DOWN. THERE WAS A RETAINED FOREIGN BODY, WHICH APPEARED TO BE A PREVIOUSLY PLACED ECHO MESH (DEVICE #1, #2 & #3). THIS WAS NOTED TO BE INTRACORPOREAL IN THE CECUM AND WAS REMOVED IN ITS ENTIRETY.¿" }, { "mdr_text_key": "371462985", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES SURGICAL INTERVENTION AND GENERAL ALLEGATIONS FOR \"PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT\"; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT BRAND NAME & PMA/510(K) #. ROOT CAUSE IS INCONCLUSIVE; NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. NOTE, THE MANUFACTURING DATE (15-JAN-2017) IS CONSIDERED TO BE A BEST ESTIMATE. UPDATED FIELDS: A2, B2, B4, B5, B6, B7, D4, D.6B (DATE OF EXPLANT), G3, G6, H2, H4, H6, H10, H11. CORRECTED FIELD: D.1 (BRAND NAME), G.4 (PMA/510(K) #). THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD/DAVOL VENTRALIGHT ST W/ ECHO (DEVICE #2). ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALIGHT ST W/ ECHO (DEVICE #1) AND ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALIGHT ST W/ ECHO (DEVICE #3). NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "SAN GERONIMO INDUSTRIAL PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "02886", "manufacturer_contact_exchange": "401", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/28/2025" } ] }