BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULKAMID

    MDR report key: 24570743 · Received March 11, 2026

    Report

    Report Number
    2124215-2026-13626
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 21, 2026
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    UDI-DI
    10810005340509
    PMA / PMN Number
    P170023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF CANCELLED PROCEDURE, POST SEDATION/UNKNOWN. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) WAS PROVIDED BY THE SOURCED FINISHED MEDICAL DEVICE (SFMD) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED HAS BEEN CHOSEN.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF CANCELLED PROCEDURE, POST SEDATION/UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BULKAMID WAS USED DURING A PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THERE WAS A LEAK FROM THE SYRINGE. IT WAS REPORTED AS AN UNSUCCESSFUL IMPLANT. THE TYPE OF ANESTHESIA UTILIZED WAS NOT REPORTED. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BULKAMID WAS USED DURING A PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THERE WAS A LEAK FROM THE SYRINGE. IT WAS REPORTED AS AN UNSUCCESSFUL IMPLANT. THE TYPE OF ANESTHESIA UTILIZED WAS NOT REPORTED. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50763 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50050 AU2F244202 10810005340509

    Patients

    Seq Age Sex Outcome Treatment
    1