BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRY & STORE - EU

    MDR report key: 19988882 · Received August 15, 2024

    Report

    Report Number
    6000034-2024-02854
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 20, 2024
    Report Date
    August 15, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DRY & STORE DOESN'T WORK AND SPARKING. A NEW REPLACEMENT DRY & STORE WERE SENT TO THE PATIENT. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619511 DRY & STORE - EU NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CP800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female Other