OtherJZR
GELBODIES
Received Oct 20, 2006
Report 8020869-2006-00001 · MDR key 777190
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Erythema
- Injury
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PATIENT REPORTED AN INJURY, WHEN USING HEEL / ELBOW GELBODIES, SIZE MEDIUM, AFTER USING THE PRODUCT FOR 2 WEEKS, THE PATIENT HAD A VERY RED AREA ON HER HEEL, WHICH REQUIRED NURSING CARE FROM A WOUND CARE SPECIALIST.
Additional Manufacturer Narrative
FURTHER INFORMATION REQUESTED TO DETERMINE IF THE INCIDENT RESULTED IN SERIOUS INJURY. HAVE REQUESTED THAT THE DEVICE BE RETURNED FOR EVALUATION. AT THIS STAGE NOT POSSIBLE TO DETERMINE CAUSE.