BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST OIL W/ FILTER, AL-II/III

    MDR report key: 3984022 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16377
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    August 19, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 5. REPORT WAS RECEIVED FROM (B)(6), STATING THAT THE DEVICE HAD A POORLY CUT/MISSHAPENED FILTER. IT IS UNK IF THE DEVICE WAS USED IN SURGERY. IT IS UNK IF INJURIES OR MEDICAL INTERVENTION WERE OCCURRED. THE DATE OF EVENT IS UNK. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663307 INST OIL W/ FILTER, AL-II/III GEY DEPUY SYNTHES POWER TOOLS E273051077

    Patients

    Seq Age Sex Outcome Treatment
    1