D-ACTOR

Description of Event or Problem

PATIENT COMPLAINT OF SUDDEN HEARING LASS AND LOUD TINNITUS AS SOON AS IT CONTACTED THE MASTOID/OCCIPITAL BONE AFTER RADIAL SHOCKWAVE THERAPY. PATIENT REPORTS TO NOT WEARING EAR PORTECTION DURING TREATMENT.

Additional Manufacturer Narrative

THE ENERGY/TRANSMITTER USED ARE APPARENTLY FLNE. A POSSIBLE ISSUE IS THAT THE TRANSMITTER HAS BEEN IN DIRECT CONTACT TO THE MASTOID/OCCIPITAL BONE. IN THE INSTRUCTIONS FOR USE WE WARN AGALNST THE APPLICATION OF PULSES TO ANY REGIONS NEAR THE HEAD. EVEN THOUGH THE NOISE LEVEL OF PULSES IS WITHIN THE SAFE RANGE, WE RECOMMEND WEARING SUITABLE EAR PROTECTION DURING TREATMENT IN ORDER TO MINIMISE EXPOSURE TO NOISE.