BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 901065 · Received August 23, 2007

    Report

    Report Number
    2210968-2007-00749
    Event Type
    Injury
    Date Received
    August 23, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 8/22/2007. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION D4, H4: THE BATCH NUMBER FOR THE DEVICE INVOLVED IN THIS EVENT IS UNKNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCT BATCH NUMBERS: 1074515, 1076534, 1083226 AND 1086504.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE IN 2003. AN ABDOMINAL SLING DEVICE AND A SOFT MESH DEVICE WERE USED DURING THE PROCEDURE. IN 2005 OR 2006, THE PATIENT DEVELOPED BLADDER CALCULI, AND RECEIVED UNSPECIFIED TREATMENT FOR THE CALCULI. MESH EXTRUSION INTO THE BLADDER WAS NOTICED DURING TREATMENT OF THE CALCULI. THERE WAS A RECURRENCE OF BLADDER CALCULI IN 2007 AND THE PATIENT RECEIVED UNSPECIFIED TREATMENT IN 2007. THE SURGEON SUSPECTS THAT THE SLING DEVICE "FRAYED WITH TISSUE" DURING PLACEMENT AND THE BROKEN FIBER EXPOSED INTO THE BLADDER. THE EXTRUDED MESH WAS RETRIEVED ON AN UNKNOWN DATE, AND THE PATIENT IS IN STABLE CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention PROLENE MESH (PMII)