{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 292 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "10028323", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200506", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200317", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "report_date": "20200401", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200506", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "493527", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200506", "brand_name": "TELFA", "generic_name": "GAUZE/SPONGE, INTERNAL", "manufacturer_d_name": "CARDINAL HEALTH 200, LLC", "manufacturer_d_address_1": "785 FORT MILL HWY", "manufacturer_d_address_2": "", "manufacturer_d_city": "FORT MILL", "manufacturer_d_state": "SC", "manufacturer_d_zip_code": "29707", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "29707", "device_operator": "I", "model_number": "", "catalog_number": "", "lot_number": "19M026062", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "EFQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Gauze/Sponge, Internal", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "U" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200506", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "3650 DA", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20200401", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200506", "manufacturer_contact_city": "", "mdr_report_key": "10028323", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20200401", "manufacturer_name": "", "report_source_code": "User Facility report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189996180", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SITUATION: RECEIVED PHONE CALL FROM PICU ANM REGARDING UNINTENTIONAL RETAINED FOREIGN OBJECT - SPONGE NOTED IN MRI POST CRANIOTOMY SURGERY. PATIENT HAD CRANIOTOMY SURGERY AND THIS AM MRI NOTED RETAINED SPONGE. PICU STAFF REPORTED EVENT TO CLINICAL RISK MANAGER ON CALL. DISCLOSURE TO PATIENT/PARENTS WAS DONE. ASSESSMENT: PER CHART (NEUROSURGERY PROGRESS NOTE): \"IN REVIEWING PATIENT'S POSTOP MRI OBTAINED THIS MORNING, THERE IS A NOTABLE T2 HYPERINTENSITY IN THE INTERHEMISPHERIC FISSURE POSTERIORLY NOT NOTED ON HER PREOPERATIVE MRI. I FELT THAT THIS IS CONCERNING FOR RETAINED FOREIGN OBJECT, SPECIFICALLY TELFA USED FOR PROTECTION OF THE CEREBRAL CORTEX DURING DISSECTION OF THE INTERHEMISPHERIC FISSURE. ALTHOUGH THE SURGICAL COUNTS WERE CORRECT AT THE END OF YESTERDAY'S OPERATIVE PROCEDURE, TELFA WAS CUT INTO STRIPS AND THEN COUNTED. THE TELFA WE USED DID NOT HAVE STRINGS ATTACHED TO FACILITATE COUNTING. IN REVIEWING WITH OTHER OPERATIVE PERSONNEL PRESENT DURING THE SURGERY, IT APPEARS THAT ONE PIECE OF COUNTED TELFA MAY HAVE BEEN CUT AGAIN AND THE COUNT NOT UPDATED. THIS MAY ACCOUNT FOR THE DISCREPANCY BETWEEN OUR CORRECT SURGICAL COUNT AND THE APPARENT RETAINED TELFA VISUALIZED ON MRI.\" RECOMMENDATION: PATIENT SCHEDULED TODAY TO GO BACK TO OR FOR REMOVAL OF RETAINED TEFLA (EXPLORATION OF LEFT FRONTAL CRANIOTOMY FOR REMOVAL OF RETAINED FOREIGN BODY (TELFA)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }