BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS PLUS VIO 96IN 1 S/A XLH LP

    MDR report key: 9083799 · Received September 18, 2019

    Report

    Report Number
    2210968-2019-87823
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 20, 2019
    Report Date
    August 23, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031048676
    PMA / PMN Number
    K061037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). IT WAS RECEIVED FOR ANALYSIS AN EMPTY OPENED FOIL, AN EMPTY OPENED FOLDER AND NEEDLE-SUTURE PIECE OF PRODUCT CODE PDP881, LOT PBM549. DURING THE VISUAL INSPECTION OF THE OPENED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED AND SLIGHTLY MARKS WERE NOTED ON THE BODY NEEDLE. THE SUTURE WAS CUT APPEARS TO BE BY USE OF SURGICAL INSTRUMENT. DUE TO THE CONDITION OF THE SAMPLE THE FUNCTIONAL TEST CANNOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. DUE TO CONDITION OF THE SAMPLE, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE ASSEMBLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877070 PDS PLUS VIO 96IN 1 S/A XLH LP SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. PBM549 10705031048676

    Patients

    Seq Age Sex Outcome Treatment
    1