InjuryISH
ICEROSS COMFORT 36
Received Nov 21, 2016 · Event occurred Dec 13, 2015
Report 3003764610-2016-00009 · MDR key 6118986
Device
Generic name
Component, External Limb, Ankle/foot
Manufacturer
Ossur IcelandModel number
I-540636Catalog number
I-540635
Lot number
441
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fall
- Injury
- Fall
- Injury
Narrative
Additional Manufacturer Narrative
LIMITED INFORMATION PROVIDED TO US THROUGH ATTORNEY. NO DETAILS RELATED TO CLAIM OF 'SIGNIFICANT INJURIES TO HIS RIGHT LEG AND OTHER PORTIONS OF HIS BODY'.
Description of Event or Problem
AMPUTEE PATIENT WALKING DOWN THE HALL AT HOME AND FELL. THERE IS A CLAIM OF SIGNIFICANT INJURIES TO HIS RIGHT LET AND OTHER PORTIONS OF HIS BODY. THE USER TOOK THE PROSTHETIC TO THE LOCAL CPO WHO RESOLVED THE ISSUE. THERAPIST CLAIMS THE PIN WORKED ITS WAY OUT OF THE SLEEVE.