BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5047878 · Received September 1, 2015

    Report

    Report Number
    2125050-2015-00090
    Event Type
    Injury
    Date Received
    September 1, 2015
    Report Date
    July 27, 2015
    Manufacturer
    COLOPLAST CORP
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. RESPONSE MADE BECAUSE DEVICE WAS NOT RETURNED. DEVICE NOT EXPLANTED OR RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH COLOPLAST PELVIC MESH PRODUCT(S). LATER, PATIENT EXPERIENCED PERMANENT INJURIES, SEVERE EMOTIONAL PAIN AND INJURY AND HAS SUFFERED AND WILL SUFFER APPREHENSION OF INCREASED RISK FOR INJURIES AND MULTIPLE CORRECTIVE SURGERIES AS A RESULT OF IMPLANTATION OF THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577536 UNKNOWN SURGICAL MESH FTL COLOPLAST CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other