BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 1760226 · Received July 12, 2010

    Report

    Report Number
    2210968-2010-00776
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Report Date
    June 11, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE WAS RECOVERED DURING THE SAME PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL ETHICON, INC. NA BJM571

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK