BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 1791306 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00877
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 6, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-00873. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LACERATION CLOSURE PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. WHILE SUTURING THE PT, THE NEEDLE BROKE. ANOTHER SIZE NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK