FDA Adverse Event
Injury
Summary report: N
ICELOCK CLUTCH 211
MDR report key: 1084682
·
Received July 29, 2008
Report
- Report Number
- 1836248-2008-00001
- Event Type
- Injury
- Date Received
- July 29, 2008
- Date of Event
- March 20, 2008
- Report Date
- April 9, 2008
- Manufacturer
- OSSUR H/F
- Product Code
- ISS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: WITHOUT POSSESSION OF THE INVOLVED DEVICE, IT IS IMPOSSIBLE TO CONDUCT AN EVALUATION OF ANY VALUE.
Description of Event or Problem · 1
"WHILE PATIENT WAS STEPPING DOWN FROM A CURB, THE LOCK FAILED AND THE PROSTHESES FELL OFF. PATIENT BROKE HIS WRIST AS A RESULT OF BRACING THE FALL." THE LOCK REFERRED TO ABOVE IS USED TO ATTACH A PROSTHETIC LIMB TO THE HARD SOCKET WHICH IS FITTED TO THE PATIENT'S RESIDUAL LIMB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICELOCK CLUTCH 211 | ISS | OSSUR H/F | L-211000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |