BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1910785 · Received November 22, 2010

    Report

    Report Number
    2210968-2010-01555
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01553 AND 2210968-2010-01554. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN LAPAROTOMY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. ALL NEEDLE PIECES WERE REMOVED DURING THE SAME PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE NEW ETHICON, INC. NA BK8KMTQ0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK