HEELMEDIX HEEL PROTECTOR
Received Feb 28, 2014 · Event occurred Jan 20, 2014
Report 1417592-2014-00023 · MDR key 3674485
Device
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Tissue Damage
Narrative
Description of Event or Problem
THE PT DEVELOPED A DEEP TISSUE INJURY TO HIS HEEL WHILE WEARING A HEEL PROTECTOR.
Additional Manufacturer Narrative
THE FACILITY REPORTED THAT A MALE PT IN THEIR ICU DEVELOPED A DEEP TISSUE INJURY TO HIS HEEL WHILE WEARING THE HEEL PROTECTOR. WE ATTEMPTED TO OBTAIN DETAILS SURROUNDING THE INCIDENT BUT THE CONTACT AT THE FACILITY INDICATED SHE DID NOT HAVE SPECIFICS. THE FREQUENCY IN WHICH SKIN ASSESSMENTS WERE PERFORMED WAS NOT REPORTED. WE DO NOT KNOW THE LENGTH OF TIME THE HEEL PROTECTOR WAS WORN OR IF IT WAS SIZED CORRECTLY. WE ALSO DO NOT KNOW IF ANY MEDICAL TREATMENT WAS INITIATED AS A RESULT OF THIS INCIDENT. WE HAVE NOT CONFIRMED THE HEEL PROTECTOR CAUSED OR CONTRIBUTED TO THE INCIDENT, BUT DUE TO THE REPORTED DEEP TISSUE INJURY AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.