BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 9535446 · Received December 31, 2019

    Report

    Report Number
    0001526350-2019-01207
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 17, 2019
    Report Date
    March 26, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOWING SECTIONS WERE UPDATED/EDITED: B4, B5, G4, G7, H2, H10. UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE SERIOUS INJURY AND HAS NOT BEEN PREVIOUSLY REPORTED AS A SERIOUS INJURY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE CUSTOMER HAS INDICATED THAT THE DEVICE IS BEING RETURNED FOR EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY A FUNCTIONAL DEFECT WITH AN ELECTRIC DERMATOME REF00-8821-001-00 SN (B)(4) OCCURRED. THE DEVICE STARTS VERY SLOWLY. THERE WAS NO HARM OR INJURY TO THE PATIENT OR THE OPERATOR. THERE WAS NO DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329923 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1