FDA Adverse Event
Malfunction
Summary report: N
ETAC WALKER SALSA
MDR report key: 2639465
·
Received June 28, 2012
Report
- Report Number
- 3008986539-2012-00048
- Event Type
- Malfunction
- Date Received
- June 28, 2012
- Date of Event
- July 1, 2007
- Report Date
- July 31, 2007
- Manufacturer
- ETAC SUPPLY CENTER AB
- Product Code
- ITJ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- 3008986539-1/27/12-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE WHEEL REPORTEDLY CAME OFF DURING HANDLING OF THE WALKER, BUT NO USER WAS INVOLVED. THE CUSTOMER DID NOT RETURN THE WALKER TO ETAC FOR EXAM. (B)(4).
Description of Event or Problem · 1
A NEW WALKER LOST A WHEEL WHEN IT WAS UNPACKED BY THE DISTRIBUTOR. THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMING OFF WAS LOOSE. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETAC WALKER SALSA | WALKER MECHANICAL | ITJ | ETAC SUPPLY CENTER AB | 15110103-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |