BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II PLUS ANTIBACTERIAL SUTURE

    MDR report key: 1664606 · Received April 15, 2010

    Report

    Report Number
    2210968-2010-00374
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 16, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAK
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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 AN UNKNOWN PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING FASCIA CLOSURE, THE NEEDLE BROKE. THE BROKEN PARTS WERE FOUND AND REMOVED DURING THE SAME PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE GAK ETHICON, INC. NA CAZ929

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK