BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUT 24IN(60CM) 6-0 BLU

    MDR report key: 8860146 · Received August 5, 2019

    Report

    Report Number
    2210968-2019-85144
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 8, 2019
    Report Date
    July 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031020672
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: SPECIFIC NUMBER OF PROCEDURES THE ISSUE OCCURRED: MULTIPLE: I HAVE ONLY SAVED PACKETS FROM 1 CASE. INFORMATION CAME AS ANECDOTAL AND OCCASIONALLY UNTIL PROVIDER SAID IT HAD BEEN HAPPENING LATELY AND IT WAS DURING A CASE. I WAS ABLE TO RETRIEVE THE PACKAGING AND FILE A COMPLAINT. FOR EACH PROCEDURE: EVENT DATE: (B)(6) 2019. QUANTITY INVOLVED: 4 PACKAGES. EVENT DESCRIPTION STATING IF NEEDLE PULL OFF OR SUTURE THREAD BROKE FOR EACH INVOLVED DEVICE, NEEDLE CAME OFF THIS INSTANCE. HOW WAS THE CASE COMPLETED? USING THE SAME TYPE OF SUTURE. ARE SAMPLES AVAILABLE FOR EVALUATION? NO THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ATTEMPTS WERE MADE TO OBTAIN THE INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE 4 DEVICES FOR THIS PATIENT REPORTED IN MEDWATCH REPORTS: 2210968-2019-85141, 2210968-2019-85142, 2210968-2019-85143, 2210968-2019-85144.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE EASILY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653250 PROLENE SUT 24IN(60CM) 6-0 BLU SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. PBJ468 10705031020672

    Patients

    Seq Age Sex Outcome Treatment
    1