BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX

    MDR report key: 4183337 · Received October 18, 2014

    Report

    Report Number
    1045834-2014-13942
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Report Date
    April 10, 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

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTED THAT THE RPM BELOW SPECIFICATIONS. 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 IT DID NOT FUNCTION AND HAD LOW POWER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663751 MICROMAX EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC ERL DEPUY SYNTHES POWER TOOLS 050000259778

    Patients

    Seq Age Sex Outcome Treatment
    1