FDA Adverse Event
Injury
Summary report: N
WALKER
MDR report key: 2624071
·
Received April 27, 2009
Report
- Report Number
- 2020250-2009-00004
- Event Type
- Injury
- Date Received
- April 27, 2009
- Date of Event
- April 1, 2007
- Report Date
- April 27, 2009
- Manufacturer
- OSSUR AMERICAS
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS INFO COMES TO US FROM AN ATTORNEY. PT CLAIMS WALKER BROKE WHICH CAUSED A TEAR IN THE CALF MUSCLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALKER | WALKER | ITJ | OSSUR AMERICAS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |