BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINA TAPE

    MDR report key: 1822847 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-01011
    Event Type
    Injury
    Date Received
    August 30, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE BETWEEN (B)(6) 2007 AND (B)(6) 2009. THE PT PRESENTED WITH A MESH EROSION BY TWELVE WEEKS POST-PROCEDURE. NO FURTHER INFO WAS PROVIDED RELATING TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention