BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAGEL 4.5ML

    MDR report key: 3103169 · Received May 9, 2013

    Report

    Report Number
    0002530131-2013-00002
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REP WAS AWARE OF THIS EVENT ON (B)(6) 2013, BUT DID NOT REPORT THE EVENT TO STRYKER UNTIL (B)(6) 2013. THE EVENT WAS NOT PROCESSED INTERNALLY UNTIL (B)(4) 2013. CORRECTIVE ACTION IS BEING TAKEN INTERNALLY DUE TO LATE REPORTING OF COMPLAINT. THIS WAS THE FIRST REPORTED COMPLAINT OF A VITAGEL COLLAGEN FILLED SYRINGE MISSING FROM KIT. THERE WAS NO REPORTED PATIENT ADVERSE EVENT OTHER THAN A 10 MINUTE PROCEDURAL DELAY. A SECOND COMPLETE KIT WAS MADE AVAILABLE AND USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    CLARIFIED EVENT DESCRIPTION-IT WAS REPORTED THAT A VITAGEL KIT WAS OPENED DURING A CASE AND THE SYRINGE CONTAINING COLLAGEN WAS ABSENT. ANOTHER BOX OF VITAGEL WAS OBTAINED AND WAS USED TO ASSIST IN FINISHING THE CASE. THE COLLAGEN SYRINGE WAS PRESENT IN THE SECOND BOX OF VITAGEL. THERE WAS NO REPORTED PATIENT INJURY HOWEVER THERE WAS A REPORTED 10 MINUTE DELAY TO OBTAIN A SECOND UNIT OF VITAGEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203935 VITAGEL 4.5ML VITAGEL LMF STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1