BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCI S&N POW/POW MAX

    MDR report key: 7244887 · Received February 6, 2018

    Report

    Report Number
    1221934-2018-50142
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 8, 2018
    Report Date
    January 8, 2018
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.¿ INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT, WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. ASSOCIATED MEDWATCH#: 1221934-2018-50143 AND 1221934-2018-50138.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THREE OF THE CUSTOMER'S 4220-3 HCI S&N POW/POW MAX -NS WERE NOT SWITCHING TO SUCTION WHEN THE SHAVERS WERE ACTIVATED DURING TESTING. THERE WAS NO PATIENT OR CASE INVOLVEMENT. THE SALES REP COULD NOT PROVIDE ANY SERIAL NUMBERS. THE DEVICES WERE DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87531 HCI S&N POW/POW MAX LINE-POWERED SHAVER SYSTEM HANDPIECE ELECTRICAL CABLE HRX DEPUY MITEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1