BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-GUARD

    MDR report key: 58198 · Received December 13, 1996

    Report

    Report Number
    2183620-1996-00007
    Event Type
    Injury
    Date Received
    December 13, 1996
    Date of Event
    November 5, 1996
    Report Date
    December 4, 1996
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    FTL
    Removal / Correction Number
    Z061/063-7
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A) CO HAS MADE 3 SEPARATE REQUESTS FOR INFO FROM THE PHYSICIAN WITH NO RESPONSE AND HAVE DECIDED TO CLOSE OUT THIS REPORT. CO NOTES THAT THE OCCURRENCE IS CONSISTENT WITH THE EVENTS LEADING TO THE ACTION OF Z-061/063-7. THIS DOES NOT REPRESENT AN OUTCOME FROM A NEW IMPLANT MADE PRIOR TO THE Z-061/063-7 ACTION. B) SEE H9, SAFETY ALERT WAS DISTRIBUTED AND "URETHRAL SLING" WAS REMOVED FROM LABELING. CO CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    INCISINAL DEHISCENCE WITH DISCHARGE 6 MONTHS AFTER TRANSVAGINAL URETHRAL SLING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-GUARD Implant SURGICAL PATCH FTL BIO-VASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention