BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5095952 · Received September 22, 2015

    Report

    Report Number
    2125050-2015-00092
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    August 14, 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). SINCE THAT TIME, THE MESH HAS PERFORATED THROUGH TO HER VAGINA AND SHE HAD NEW BLADDER PROBLEMS. SHE AND HER HUSBAND HAVE COMPLETELY LOST THEIR SEX LIFE BECAUSE IT HAS BEEN TOO PAINFUL. PATIENT RECENTLY NOTICED THAT THE MESH IS NOW PROTRUDING FROM HER RECTUM. SHE HAS BEEN EXPERIENCING PAIN AND DIFFICULTY PASSING STOOL, WITH SIGNIFICANT AMOUNTS OF BLOOD AT TIMES. SHE HAS CONSULTED 3 DOCTORS, INCLUDING THE DOCTOR THAT IMPLANTED THE MESH, ALL WITH DIFFERING OPINIONS ON HOW TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624310 UNKNOWN SURGICAL MESH FTL COLOPLAST CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other