BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 3955848 · Received July 24, 2014

    Report

    Report Number
    2210968-2014-10019
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE STERILE BARRIER WAS COMPROMISED AS A RESULT OF A TEAR. HOWEVER, THE DEVICE POSITION AND PAPER FOLDER CONDITION INDICATES THAT THE DEVICE WAS MISHANDLED AT UNKNOWN POINT AFTER IT LEFT THE CONTROLLED ENVIRONMENT. 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) 2014 AND AN ABSORBABLE STAPLE WAS USED. WHEN OPENING THE DEVICE IT WAS NOTED THAT THERE WAS A TEAR IN THE CORNER OF THE PACKAGE. A NEW LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433761 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. UNK GH6326

    Patients

    Seq Age Sex Outcome Treatment
    1