BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE A TRAP

    MDR report key: 3832023 · Received February 7, 2014

    Report

    Report Number
    2125050-2014-00196
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    April 24, 2012
    Report Date
    February 6, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K092207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PT WAS IMPLANTED WITH RESTORELLE AND OMNISURE MESH. LATER THE PT EXPERIENCED URINARY INCONTINENCE, OCCASIONAL CONSTIPATION, PAIN, MESH EXPOSURE, BOWEL PROBLEMS, INFECTION, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. A CYSTOURETHROSCOPY AND SUBSEQUENT PLACEMENT OF AN ADDITIONAL MESH PRODUCT WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79435 RESTORELLE A TRAP SURGICAL MESH FTL COLOPLAST A/S 5013001400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other