BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITOSS BBTRAUMA FOAM PACK 5CC

    MDR report key: 6578597 · Received May 19, 2017

    Report

    Report Number
    0002530131-2017-00007
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    April 20, 2017
    Report Date
    July 24, 2017
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    MQV
    UDI-DI
    00808232001334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT; RESULT: DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. DEVICE INSPECTION COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS FOR THE REPORTED LOT. CONCLUSION: BASED ON THE REPORTED EVENT, THE LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL USED EXPIRED PRODUCT. IT WAS REPORTED THAT A PACKAGE OF EXPIRED BBT WAS USED ON A PATIENT. IT WAS REPORTED THAT THE PRODUCT HAD EXPIRY DATE: SEPTEMBER 30 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL USED EXPIRED PRODUCT. IT WAS REPORTED THAT A PACKAGE OF EXPIRED BBT WAS USED ON A PATIENT. IT WAS REPORTED THAT THE PRODUCT HAD EXPIRY DATE: SEPTEMBER 30 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360380 VITOSS BBTRAUMA FOAM PACK 5CC RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV STRYKER ORTHOBIOLOGICS-MALVERN 2102-2205 B1409012 00808232001334

    Patients

    Seq Age Sex Outcome Treatment
    1