90043086 30210 FOOT PROTECTOR X72

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THERE WERE NO PHYSICAL SAMPLES RECEIVED WITH THIS COMPLAINT THEREFORE AN EXAMINATION OF THE SAMPLES COULD NOT BE MADE TO CONFIRM THE REPORTED ISSUE AND DETERMINE THE ROOT CAUSE. A PHOTO WAS PROVIDED SHOWING THE PATIENTS SKIN CONDITION; HOWEVER, IT IS UNCLEAR FROM THE PHOTO IF THERE ARE ANY ISSUES WITH THE PRODUCT ITSELF. IT SHOULD BE NOTED THAT THIS PRODUCT IS INTENDED TO BE USED DURING SURGERY. PER THE DETAILS IN THE COMPLAINT, THE PRODUCT WAS IN USE FOR 3 DAYS, THIS MAY BE A POSSIBLE ROOT CAUSE. IT WOULD BE ADVISED THAT A HEEL OFF LOADING DEVICE BE USED FOR LONG TERM SUPPORT. NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE INVESTIGATION WILL RESUME AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

SUBMIT DATE: 02/01/2016.SUBMIT DATE:AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A FOOT PROTECTOR. THE CUSTOMER REPORTS: THE PATIENT HAD DEVON BOOTS FOR PRESSURE RELIEF YET WE FIND HER WITH SKIN DISCOLOURATION ON HER FEET. SUBSEQUENTLY THE PATIENT DEVELOPED A STAGE 3 ULCER ON HER FOOT.