BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 3820525 · Received May 20, 2014

    Report

    Report Number
    2210968-2014-06059
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DEVICE POSITION AND PAPER FOLDER CONDITION INDICATES THAT THE DEVICE WAS MISHANDLED AT UNKNOWN POINT AND CANNULA AND PAPER FOLDER IMPACTED THE SEAL AREA, THEREFORE THE STERILE BARRIER WAS COMPROMISED AS A RESULT OF A SEVERE NON-NORMAL HAZARD AFTER IT WAS SHIPPED TO THE CUSTOMER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS ¿COMING OUT OF THE PACKAGE¿. THE DEVICE WAS NOT USED ON THE PATIENT DUE TO THE POSSIBILITY OF COMPROMISED STERILITY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298899 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. UNK GDM787

    Patients

    Seq Age Sex Outcome Treatment
    1