BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADBAND HB-7 FOR TDH39

    MDR report key: 25275443 · Received May 26, 2026

    Report

    Report Number
    9612197-2026-00011
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    May 16, 2026
    Report Date
    May 26, 2026
    Manufacturer
    NATUS SENSORY IRELAND
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT FOR INTERNAL CASE NUMBER (B)(4). WE HAVE REQUESTED THE DEVICE TO BE RETURNED. RISK REVIEW- AS PER DOC-049635 REV 15 - 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

    THE MANUFACTURER RECEIVED THE INFORMATION REGARDING AN AURICAL AUD DEVICE. THE USER REPORTED THAT THE HEADPHONE COMPLETELY SNAPPED FROM THE HEADBAND DUING USE, AND THE HEADBAND HIT THE PATIENT NEAR THE EYE ON THE RIGHT SIDE. THE PATIENT EXPERIENCED PAIN AND FLINCHED. NO BLEEDING, BRUISING OR VISIBLE INJURY WAS REPORTED. THE IMPACT WAS DESCRIBED AS STRONG. THE USER SPOKE TO OTHER STAFF, THEY MENTIONED THE HEADPHONES ARE LOOSE AND HAVE EXPERIENCED THEM COMING APART. NO MEDICAL INTERVENTION WAS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126647 HEADBAND HB-7 FOR TDH39 HEADBAND HB-7 FOR TDH39 EWO 1-25-12200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown