OSSUR ICEROSS LINER
Received Jan 14, 2004 · Event occurred Nov 30, 2003
Report 3003764610-2004-00001 · MDR key 547241
Device
Generic name
Formfitting Silicone Interface/cover For Lower Limb Ampute
Manufacturer
Ossur HfModel number
ICEROSS COMFORT LINER (LOCKING)Catalog number
I-010232
Lot number
0137, 01=2001, 37=WEEK
Product problems
- Tears, rips, holes in device, device material
Patient
53 YR
- Fall
- Bone Fracture(s)
Narrative
Description of Event or Problem
THE ICEROSS COMFORT LINER IS USUALLY THE FIRST COMPONENT IN A PROSTHETIC LEG. IT IS ROLLED ON TO THE RESIDUAL LIMB, AND IS MADE OF A SOFT, STRETCHY MATERIAL THAT ACTS AS AN INTERFACE BETWEEN THE HARD, WEIGHT-BEARING SOCKET AND THE SKIN. THE LINER PROTECTS THE LIMB AND ACTS AS AN ATTACHMENT TO THE PROSTHESIS. OSSUR ICEROSS COMFORT LINER IS AN OSSUR PRODUCT AND IS PRODUCED AT OSSUR HF. CO DOES NOT HAVE ANY INFO ABOUT WHAT TYPES (OSSUR OR SOMEONE ELSE'S PRODUCTS) OF OTHER COMPONENTS WERE USED IN THE PROSTHETIC LEG. ALL FOLLOWING INFO WAS RECEIVED FROM CO'S CONTACT PERSON, THE PROSTHETIST: DESCRIPTION OF EVENT: THE PT WAS WALKING AT THEIR HOUSE WHEN THE DISTAL ATTACHMENT TORE OUT OF THE LINER. THE PROSTHETIST THINKS THAT THE PT FELL FORWARD, SINCE THEY PUT THEIR HANDS OUT TO CATCH THEMSELVES BUT THEY ALSO SAID THAT THERE WAS NO WAY TO CONCLUDE HOW THE PT FELL. WHEN THEY FELL, THEY BROKE THEIR WRIST. CO DOES NOT HAVE ANY INFO ABOUT WHY OR HOW THEY FELL, NOR WHAT BROKE IN THEIR WRIST. THE PT'S WRIST WAS PUT IN A SEMI-RIGID BRACE AND THEN LATER IN A CAST. NO FURTHER INFO IS AVAILABLE REGARDING THE TREATMENT. THE PT HAS OTHER HEALTH PROBLEMS.
Remedial action
- Patient Monitoring
- Replace
- Other