HEADBAND HB-7 FOR TDH39

Additional Manufacturer Narrative

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

THE MANUFACTURER RECEIVED THE INFORMATION REGARDING THE HEADBAND HB-7 FOR TDH39 . THE USER HAS INFORMED ABOUT THE LOOSE HB-7 BRACKET. THE HB-7 BRACKET HAS COME LOOSE AND HIT PATIENT ON THE HEAD, RESULTING IN MINOR INJURIES. NO MEDICAL INTERVENTION WAS REQUIRED AT THIS TIME.