BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 406048 · Received July 10, 2002

    Report

    Report Number
    2210968-2002-00661
    Event Type
    Injury
    Date Received
    July 10, 2002
    Date of Event
    January 1, 1999
    Report Date
    June 10, 2002
    Manufacturer
    MEDSCAND MEDICAL AB
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE ACTA OBSTRICA E T GYNECOLOGICA SCANDINAVIA 2002; 81: 72-77, THAT FOLLOWING A SLING PROCEDURE THE VAGINAL INCISION DID NOT HEAL PROPERLY. THE AREA WAS RESUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE TVT DEVICE FTL MEDSCAND MEDICAL AB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention