BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3161649 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-06939
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFECTION OCCURED. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED THE MESH DISINTEGRATED CAUSING INFECTION LEADING TO REMOVAL. THE PATIENT EXPERIENCED LONG TERM INFECTIONS AND DISCOMFORT. SHE WAS TREATED UNSUCCESSFULLY WITH TEN DIFFERENT ANTIBIOTICS AND HOSPITAL ADMISSIONS. THE PATIENT STATED TREATMENT IS STILL ONGOING AFTER SEVEN YEARS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262893 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R