BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES¿ ULTRA 3D IMPLANT

    MDR report key: 21787353 · Received April 7, 2025

    Report

    Report Number
    3006556115-2025-00469
    Event Type
    Injury
    Date Received
    April 7, 2025
    Report Date
    March 24, 2025
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECIPIENT REPORTEDLY COMPLETED ANTIBIOTIC TREATMENT AND DRAINAGE HAS RESOLVED. THE RECIPIENT WAS SUCCESSFULLY ACTIVATED. NO FURTHER FOLLOW UP. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Description of Event or Problem · 0

    THE RECIPIENT PRESENTED WITH CLEAR FLUID DRAINING FROM IMPLANT SITE FROM A TM PERFORATION, LIKELY CAUSED BY Q-TIP OVERUSE. THE RECIPIENT WAS TREATED WITH ANTIBIOTICS (TREATMENT UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847634 HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention