BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 96IN 1 S/A XLH LP

    MDR report key: 12301321 · Received August 10, 2021

    Report

    Report Number
    2210968-2021-07170
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 15, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031061927
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER QMMCDK AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. (B)(4). TO DATE THE DEVICE HAS NOT BEEN 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 THAT A PATIENT UNDERWENT A GASTRIC TUMOR RESECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE CLOSING THE FASCIA. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201415 PDSII VIO 96IN 1 S/A XLH LP SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. Z881G QMMCDK 10705031061927

    Patients

    Seq Age Sex Outcome Treatment
    1