BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADBAND HB-7 FOR TDH39

    MDR report key: 23802540 · Received December 15, 2025

    Report

    Report Number
    9612197-2025-00014
    Event Type
    Injury
    Date Received
    December 15, 2025
    Report Date
    December 15, 2025
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S HEAD HURT. DEVICE REQUESTED FOR RETURN. 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. FILE ATTACHMENTS.

    Description of Event or Problem · 0

    HEADSET CRACKS AND THE METAL HOLDER FOR TDH-39 SNAPS LOOSE AND HURTS THE PATIENTS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272895 HEADBAND HB-7 FOR TDH39 HEADBAND HB-7 FOR TDH39, EWO NATUS MEDICAL DENMARK 1-25-12200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown