HEEL RAISER, PROTECTOR
Received Mar 21, 2014
Report 1417592-2014-00032 · MDR key 3698632
Device
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
THE FACILITY REPORTED THAT THERE WERE MULTIPLE REPORTS OF STAGE II ULCERS ASSOCIATED WITH THE USE OF THE HEEL PROTECTOR. NO OTHER DETAILS WERE PROVIDED. WE HAVE NO SAMPLE AND NO LOT NUMBER. THE FACILITY DID NOT RESPOND TO MULTIPLE REQUESTS ASKING FOR MORE INFORMATION. WE DO NOT KNOW HOW LONG THE HEEL PROTECTORS WERE LEFT IN PLACE AND WHETHER REGULAR SKIN ASSESSMENTS HAD TAKEN PLACE. WE DO NOT KNOW HOW MANY INCIDENTS OCCURRED AND IF ANY MEDICAL INTERVENTION WAS INDICATED. WE HAVE NOT CONFIRMED THAT THE HEEL PROTECTORS CAUSED OR CONTRIBUTED TO THE INCIDENTS BUT IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.
Description of Event or Problem
THE FACILITY REPORTED THAT PATIENTS DEVELOPED STAGE II DECUBITUS ULCERS WHILE WEARING THE HEEL PROTECTORS.