BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VLOC 90 3/0 VL 12 GS-21

    MDR report key: 2887802 · Received December 14, 2012

    Report

    Report Number
    1219930-2012-00996
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K100257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: SUTURE USED ON A DAVINCI HYSTERECTOMY ON THE VAGINAL CUFF RESULTED IN WOUND DEHISCENCE AND EVISCERATION. THIS SURGERY WAS PERFORMED BY THE SAME SURGEON AS A PREVIOUS FTR REPORT THAT STATED BOWEL OBSTRUCTION FROM A MYOMECTOMY. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VLOC 90 3/0 VL 12 GS-21 VLOC GAM COVIDIEN, FORMERLY US SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other