BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX-PLUS_AO

    MDR report key: 4183247 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-13935
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE CAME IN FOR SERVICE AND WAS REPAIRED BY TECHNICIAN. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE DEVICE REPORTING THE HAND PIECE WAS GETTING HOT AT THE DISTAL END AND RUNS CONTINUOUSLY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660691 MICROMAX-PLUS_AO EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL ERL DEPUY SYNTHES POWER TOOLS 050000257519

    Patients

    Seq Age Sex Outcome Treatment
    1