BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1790009 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00895
    Event Type
    Injury
    Date Received
    August 2, 2010
    Report Date
    July 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - URINARY RETENTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL 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 ON AN UNK DATE. POST-OPERATIVELY, THE PT HAD TO SELF CATHETERIZE. THE PT WAS TAKEN BACK TO SURGERY AND THE DEVICE WAS RE-ADJUSTED. THE PT IS NOW HAVING PRESSURE, ESPECIALLY AT NIGHT AND SHE FEELS THE DEVICE. SHE IS ALSO NOT EMPTYING HER BLADDER AND HAS STARTED TO SELF CATHETERIZE HERSELF. THE PT HAS AN APPOINTMENT AT THE END OF THE WEEK WITH HER PHYSICIAN. SHE HAS NOT CALLED THE DOCTOR TO LET HIM/HER KNOW THAT SHE HAS STARTED SELF CATHETERIZATION AGAIN. NO FURTHER INFO IS AVAILABLE.

    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 UNK Required Intervention