BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3033709 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03436
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION : NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF VOLUNTARY MEDWATCH REPORT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2008. THE PATIENT EXPERIENCED A URINARY TRACT INFECTION AND WENT FOR A CYSTOSCOPY WITH COMPLICATED REMOVAL OF A FOREIGN BODY FROM THE BLADDER ON (B)(6) 2013. THE FOREIGN BODY WAS A LONG PIECE OF MESH EXTENDING FROM HER DOME INTO WHAT APPEARED TO BE THE BLADDER NECK/PROXIMAL URETHRA ON THE LEFT SIDE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136522 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3146784

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention