InjuryIPG
PROCARE POST OP SHOE
Received Nov 5, 2020 · Event occurred Sep 29, 2020
Report 9616086-2020-00037 · MDR key 10791197
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
HEALTH PROFESSIONAL, OCCUPATION: UNKNOWN. MFR SITE: UNKNOWN. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT "THERE WAS A QUALITY ISSUE WITH THE DEVICE (REGARDING THE VELCRO STRAPS) THAT RESULTED IN FOOT WOUNDS (SKIN DAMAGE) TO THE PATIENT." THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.