BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CP1150 SOUND PROCESSOR (CHOCOLATE BROWN)

    MDR report key: 15757201 · Received November 8, 2022

    Report

    Report Number
    6000034-2022-03356
    Event Type
    Injury
    Date Received
    November 8, 2022
    Report Date
    October 19, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED SCAB AT THE MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456241 CP1150 SOUND PROCESSOR (CHOCOLATE BROWN) NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CP1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention