AIRCAST XP DIABETIC WALKER SYSTEM, L
Received Oct 16, 2019 · Event occurred Sep 19, 2019
Report 9616086-2019-00069 · MDR key 9198298
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
ONE XP DIABETIC WALKER SYSTEM, L, LOT NUMBER 190417-AA, WAS RETURNED FOR EVALUATION. PRODUCT CONDITIONS WERE VISUALLY EVALUATED AND TESTED. THE PRODUCT IS IN GOOD CONDITION. NO DEFECT WAS FOUND. HOWEVER, THE PRODUCT WAS MODIFIED. THERE WAS A PIECE OF FOAM BETWEEN THE LINER AND THE AIR CELL. THERE WAS NO EVIDENCE (FRAGMENTATION OR MARKING) ON THE LINER THAT WOULD PROVE CONTACT OR FRICTION BETWEEN THE SKIN AND THE LINER. THE AIR CELLS WERE TESTED AND INFLATED / DEFLATED CORRECTLY. INSTRUCTIONS FOR USE STATE "LIKE ALL LOWER EXTREMITY IMMOBILIZERS, SUCH AS CASTS OR BRACES, PATIENTS WITHOUT SENSATION (I.E. POSTOP ANESTHESIA, NEUROPATHIES, ETC.) SHOULD BE MONITORED FREQUENTLY FOR "HOT SPOTS", SKIN IRRITATION OR WOUND MANAGEMENT." THIS PRODUCT IS INTENDED FOR PEOPLE WITH DIABETES, WHICH IS COMMONLY ASSOCIATED WITH NEUROPATHY IN THE LOWER EXTREMITIES.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS PENDING COMPLETION OF EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT, AFTER A SHORT TIME OF WEARING, AN ULCER FORMED ON THE LATERAL SIDE OF THE DIABETIC PATIENT'S ANKLE. THE ORTHOPAEDIC TECHNICIAN EXPLAINED ON TELEPHONE THAT THE ANKLE OF THE PATIENT IS SLIGHTLY TILTED TO THE OUTSIDE. THIS ANOMALY CAUSED THE ANKLE TO WEAR THROUGH THE INNER CUSHION AND RUBBING ON THE PLASTIC FRAME. PICTURES PROVIDED BY THE REPORTER SHOW SEVERE, COMPLETE EROSION OF A LARGE AREA OF THE PATIENT'S SKIN AROUND THE ANKLE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.