{ "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": 17035 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1018233-2020-02827", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K000723", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER", "DISTRIBUTOR", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464441", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "MAGIC3¿ COUDE INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE", "generic_name": "MAGIC 3 CATHETER", "manufacturer_d_name": "C.R. 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(COVINGTON) -1018233", "manufacturer_d_address_1": "8195 INDUSTRIAL BLVD", "manufacturer_d_address_2": "", "manufacturer_d_city": "COVINGTON", "manufacturer_d_state": "GA", "manufacturer_d_zip_code": "30014", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "30014", "device_operator": "LAY USER/PATIENT", "model_number": "50614", "catalog_number": "50614", "lot_number": "UNK", "other_id_number": "", "device_availability": "No", "device_report_product_code": "KOD", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00801741068089", "udi_public": "(01)00801741068089", "openfda": { "device_name": "Catheter, Urological", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2", "registration_number": [ "1018233" ], "fei_number": [ "1018233" ] } } ], "product_problems": [ "Biocompatibility", "Biocompatibility", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/12/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Urinary Tract Infection", "Urinary Tract Infection" ] } ], "distributor_city": "", "date_report": "20200515", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000502", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315539558", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT EXPERIENCED A UTI WITH USE OF CATHETER. IT IS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE UTI." }, { "mdr_text_key": "315539559", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE \"DEVICE USED IMPROPERLY\". A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE \"DEVICE USED IMPROPERLY\". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: \"INSTRUCTIONS FOR USE INTENDED USE: THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. PLEASE CONTACT YOUR PHYSICIAN TO DETERMINE WHICH PRODUCT OPTIONS ARE BEST FOR YOU, PAYING CLOSE ATTENTION TO PRODUCT WARNINGS/ PRECAUTIONS AND ADVERSE REACTIONS. WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. RELEASE THE STERILE WATER FROM THE FOIL PACKET. TIP THE CATHETER POUCH END-TO-END THREE TO SIX TIMES SO THE WATER MOVES BACK AND FORTH TO THOROUGHLY WET THE CATHETER SURFACE. PEEL OPEN THE PACK AT THE FUNNEL END JUST ENOUGH TO EXPOSE THE INSERTION SLEEVE. DON¿T REMOVE THE CATHETER YET. USE THE ADHESIVE TAB AT THE FUNNEL END OF THE PACK TO STICK THE PACK TO A NEARBY VERTICAL SURFACE WHILE PREPARING TO CATHETERIZE. WASH THE AREA AROUND THE MEATUS BEFORE CATHETERIZING. WASH YOUR HANDS AGAIN. HOLD THE INSERTION SLEEVE WITH YOUR DOMINANT HAND AND SQUEEZE IT TO GRIP THE CATHETER SHAFT AS YOU REMOVE THE CATHETER FROM THE PACK. NEXT, HOLD THE CATHETER FUNNEL ABOVE THE INSERTION SLEEVE WITH YOUR OTHER HAND AND SLIDE THE INSERTION SLEEVE DOWN THE SHAFT, STOPPING AT ABOUT 6¿ FROM THE TIP. RELEASE THE FUNNEL. USING THE INSERTION SLEEVE TO HOLD THE CATHETER FIRMLY, GENTLY PASS THE TIP OF THE CATHETER INTO YOUR URETHRA UNTIL THE INSERTION SLEEVE NEARS THE MEATUS. REPEAT UNTIL URINE STARTS TO FLOW. TRY TO KEEP THE CATHETER STEADY UNTIL URINE STOPS FLOWING. WHEN URINE STOPS FLOWING, SLOWLY WITHDRAW THE CATHETER, STOPPING IF FLOW STARTS AGAIN, UNTIL THE LAST FEW DROPS HAVE DRAINED. FINISH BY DISPOSING OF THE CATHETER AND ITS PACKAGING. WASH YOUR HANDS WITH SOAP AND WATER. WARNING: THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE. MADE OF SILICONE ELASTOMER.\" H11: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. THE DEVICE WAS NOT RETURNED." }, { "mdr_text_key": "189326881", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED." }, { "mdr_text_key": "189326882", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT EXPERIENCED A UTI WITH USE OF CATHETER. IT IS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE UTI." } ], "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": "05/15/2020" } ] }