BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM

    MDR report key: 3042858 · Received April 9, 2013

    Report

    Report Number
    1719045-2013-00915
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXC
    PMA / PMN Number
    K031555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR DIAGNOSIS AND NOT TREATMENT. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT US-27-1853 REVEALED THE PROBE FOR COMPARTMENTAL PRESSURE MONITORING WAS MANUFACTURED BY MIPM (B)(4). PO (B)(4), DATED (B)(4) 2012, FOR 1 PART WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE WAS DATED (B)(4) 2012. ONE PART WAS RELEASED TO THE WAREHOUSE ON (B)(4) 2012. NO NON CONFORMANCES WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT IS REPORTED BY SYNTHES (B)(4) AS FOLLOWS: ON (B)(6) 2012 THE PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM DID NOT FUNCTION ON THE FIRST USE. THE DEVICE WAS USED FOR A SECOND TIME AND WAS NOTED THAT THE CABLE CONNECTION ON THE END OF THE DEVICE WAS NOT SEALED PROPERLY. THIS IS 1 OF 1 REPORTED FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145942 PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM LXC SYNTHES MONUMENT US-27-1853

    Patients

    Seq Age Sex Outcome Treatment
    1