BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACU-LOC 1 PLATES

    MDR report key: 2840295 · Received April 19, 2012

    Report

    Report Number
    3025141-2012-00044
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Report Date
    March 15, 2012
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT (MDR # 3025141-2012-00044) AND MDR # 3025141-2012-00045 WERE INITIALLY REPORTED TO ACUMED PRODUCT MANAGEMENT (B)(4) 2012, HOWEVER, ACUMED QUALITY ASSURANCE (DESIGNEE FOR COMPLAINT HANDLING) WAS NOT AWARE OF THESE EVENTS UNTIL (B)(4) 2012.

    Description of Event or Problem · 1

    SALES REPRESENTATIVES (NOT EMPLOYED BY ACUMED) SAID THAT THEY HAD A FEW FLEXOR TENDON RUPTURES WITH THE VOLAR DISTAL RADIUS ACU-LOC 1 PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACU-LOC 1 PLATES HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1