BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVECARE +SFT SYSTEM WARNING:

    MDR report key: 10421307 · Received August 18, 2020

    Report

    Report Number
    0001526350-2020-00687
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE AN EVALUATION OF THIS DEVICE IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED. DEVICE PRODUCT CODE: JOW.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE PATIENT THE CORD IS BROKEN AND IT HAS SNAPPED WHILE UNPLUGGING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882936 ACTIVECARE +SFT SYSTEM WARNING: SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1