BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC CARNIOTOME

    MDR report key: 3963897 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14435
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    January 20, 2011
    Report Date
    January 26, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR IF ADD'L INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT THE DEVICE WOULD NOT FUNCTION. THE DEVICE WAS BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652625 PEDIATRIC CARNIOTOME HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1