BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1150504 · Received September 4, 2008

    Report

    Report Number
    2210968-2008-00789
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    August 11, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/04/2008. - MESH TORN - CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN 2008. THE DEVICE WAS REMOVED AND REPLACED WITH A DIFFERENT TYPE OF SLING DEVICE TWO MONTHS LATER, BECAUSE THE LEFT SIDE HAD A SLIT. THE SURGEON OPINED THAT THE DEVICE WAS DEFECTIVE AND REPLACED IT. THE PATIENT WAS STILL LEAKING. NO FURTHER INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention