ZIMMER AIR DERMATOME

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN TIME, ON AN UNKNOWN DATE, THE UNIT WAS TEARING THE SKIN. IT IS UNKNOWN IF THERE WAS A PATIENT IMPACT OR IF A DELAY OCCURRED. DUE DILIGENCE IS IN PROGRESS, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. G2: FOREIGN: CANADA.