PROCARE
Received Jan 11, 2012 · Event occurred Dec 12, 2011
Report 9616086-2012-00003 · MDR key 2419393
Device
Generic name
Procare Post Op Boot
Manufacturer
Djo Llc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fall
- Injury
Narrative
Additional Manufacturer Narrative
NO ADD'L INFO WAS PROVIDED. SPECIFIC INFO OF THE INVOLVED DEVICE AND THE NATURE OF THE CLAIMED INJURIES IS NOT KNOWN AT THIS TIME. THE PRODUCT WAS NOT RETURNED FOR EVAL OR INVESTIGATION.
Description of Event or Problem
RECEIVED NOTIFICATION FROM A LAW FIRM CLAIMING THAT THEIR CLIENT FELL "[AS] A RESULT OF THE POST OPERATIVE BOOT MANUFACTURED BY PRO-CARE [¿] AND AS A RESULT OF THIS FALL, SHE SUSTAINED SUBSTANTIAL AND PERMANENT INJURIES FOR WHICH SHE WILL REQUIRE SURGICAL INTERVENTION." NO ADD'L INFO WAS PROVIDED. SPECIFIC INFO OF THE INVOLVED DEVICE AND THE NATURE OF THE CLAIMED INJURIES IS NOT KNOWN AT THIS TIME. THE PRODUCT WAS NOT RETURNED FOR EVAL OR INVESTIGATION.