BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADBAND HB-7 FOR TDH39

    MDR report key: 23815055 · Received December 16, 2025

    Report

    Report Number
    9612197-2025-00016
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 7, 2025
    Report Date
    December 16, 2025
    Manufacturer
    NATUS SENSORY IRELAND
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT FOR INTERNAL CASE NUMBER: (B)(4). RISK REVIEW: AS PER (B)(4) REV 13 - 1081 AURICAL AUD & MADSEN A450 - RISK ANALYSIS: HAZARD ID 6.5. CAUSE- MECHANICAL BREAKAGE, CAUSING SHARP CORNER, EDGES OR PINCH POINTS. E.G. DUE TO STEADY FORCE APPLIED ON THE DEVICE. (HIT BY SOMETHING). EFFECTS/HARM - MINOR PHYSICAL TRAUMA INJURIES. RESIDUAL RISK 3 (LOW) AND ACCEPTABLE.

    Description of Event or Problem · 0

    AT (B)(6) SCAN, WE WERE INFORMED THAT THE HEADSET DETACHED AND STRUCK THE PATIENT'S FACE, CAUSING AN INJURY, AND THAT THE PATIENT MADE A SER IOUS COMPLAINT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943310 HEADBAND HB-7 FOR TDH39 HEADBAND HB-7 FOR TDH39, EWO 1-25-12200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown