BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 27IN 4-0 S/A SH-1

    MDR report key: 9272064 · Received November 4, 2019

    Report

    Report Number
    2210968-2019-89438
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    August 27, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052178
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION HAVE BEEN MADE AND THE FOLLOWING WAS OBTAINED: WAS RESUTURING DONE? PLEASE REFER TO THE EVENT DESCRIPTION, NO FURTHER INFORMATION CAN BE PROVIDED. WERE ANY MEDICINE'S PRESCRIBED? PLEASE REFER TO THE EVENT DESCRIPTION, NO FURTHER INFORMATION CAN BE PROVIDED. DEVICE RETURN STATUS COULD NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. ON (B)(6) 2019, 35 DAYS AFTER SEWING, THERE WAS AN INCISION SPOT EXPOSED IN CESAREAN SECTION. THE SUTURE SPITTING FROM THE INCISION. DRESSING CHANGE WAS GIVEN AND THE SUTURE WAS REMOVED. THEN THE PATIENT'S CONDITION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068235 VCL+ VIO 27IN 4-0 S/A SH-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. MK8CJPS0 10705031052178

    Patients

    Seq Age Sex Outcome Treatment
    1