BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GKC WATCH

    MDR report key: 17523611 · Received August 12, 2023

    Report

    Report Number
    MW5130559
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    February 3, 2022
    Manufacturer
    GKC MANUFACTURING PTY LTD
    Product Code
    GYD
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE GKC WATCH WAS RETURNED AFTER THE VISIT OCCURRED AND THE TABLET WOULD NOT UPLOAD DATA FROM THE WATCH PROPERLY. THE PKG CLINIC APP ON THE TABLET KEPT CRASHING AND WOULD NOT WORK. IT WAS INDICATED THAT THE ISSUE WAS RELATED TO THE PKG WATCH. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869061 GKC WATCH TRANSDUCER, TREMOR GYD GKC MANUFACTURING PTY LTD PKG/GKC WATCH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown