BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II PLUS ANTIBACTERIAL SUTURE

    MDR report key: 2030252 · Received March 21, 2011

    Report

    Report Number
    2210968-2011-00309
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00310 AND MEDWATCH 2210968-2011-00311. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SNAPPED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II PLUS ANTIBACTERIAL SUTURE SUTURES, ABSORBABLE NEW ETHICON, INC. NA CJ6439

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK