BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1790016 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00897
    Event Type
    Injury
    Date Received
    August 2, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - URGE INCONTINENCE, URINARY TRACT INFECTION OCCURRED. CONCLUSION CODES: 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 THREE YRS AGO. APPROX TWO WEEKS AFTER THE PROCEDURE, THE PT HAD A SEVERE URINARY TRACT INFECTION WHICH REQUIRED ANTIBIOTICS. SHE THEN HAD REPEATED EPISODES OF URINARY TRACT INFECTIONS. SIX WEEKS AFTER THE PROCEDURE, THE PT DEVELOPED URGE INCONTINENCE. THE PT WAS REFERRED BACK TO THE HOSP FOLLOWING ONSET OF URGE INCONTINENCE AND UNDERWENT A CYSTOSCOPY AND URODYNAMICS BUT NO CAUSE WAS FOUND OR FURTHER TREATMENT GIVEN. ADDITIONAL INFO HAS BEEN REQUESTED.

    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