BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM

    MDR report key: 8514265 · Received April 15, 2019

    Report

    Report Number
    3005099803-2019-01845
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 23, 2017
    Report Date
    April 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTO
    PMA / PMN Number
    K051245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #, MANUFACTURE DATE: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFORM DEVICE WAS USED DURING AN ANTERIOR AND POSTERIOR VAGINAL WALL MESH PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED MESH EROSION AND VAGINAL WALL MESH EXPOSURE. ON (B)(6) 2017, ONE MESH FIBER EXPOSURE OCCURRED IN THE MIDDLE OF THE VAGINAL STUMP. IT WAS NOT ENOUGH TO BE REMOVED, SO ESTRIOL WAS PRESCRIBED. ON (B)(6) 2017, 1MM OF THE EXPOSED MESH FIBER IN THE MIDDLE OF THE VAGINAL STUMP WAS REMOVED. ESTRIOL WAS STILL PRESCRIBED. REPORTEDLY, TREATMENT WAS BEING CONTINUED AND THERE WAS NO SEXUAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306576 POLYFORM MESH, SURGICAL, POLYMERIC OTO BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention