BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE, PRODUCT CODE: ERL

    MDR report key: 3454431 · Received August 28, 2013

    Report

    Report Number
    1045834-2013-04695
    Event Type
    Malfunction
    Date Received
    August 28, 2013
    Date of Event
    October 27, 2011
    Report Date
    November 2, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT REC'D FROM (B)(6) STATING THAT THE DEVICE HAD A DAMAGED HOSE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424431 DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE, PRODUCT CODE: ERL ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1