BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CP910 PROCESSING UNIT (SMOKE)

    MDR report key: 7107276 · Received December 11, 2017

    Report

    Report Number
    6000034-2017-02271
    Event Type
    Injury
    Date Received
    December 11, 2017
    Report Date
    December 1, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON DECEMBER 12, 2017, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN REACTION AND INFECTION AT IMPLANT SITE, SUBSEQUENTLY THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883413 CP910 PROCESSING UNIT (SMOKE) NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LTD CP910 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention