FDA Adverse Event
Malfunction
Summary report: N
ETAC WALKER ONO
MDR report key: 2639449
·
Received June 28, 2012
Report
- Report Number
- 3008986539-2012-00018
- Event Type
- Malfunction
- Date Received
- June 28, 2012
- Date of Event
- February 1, 2009
- Report Date
- February 16, 2009
- 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
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE WHEEL CAME OFF DURING HANDLING OF THE WALKER. NO USER WAS INVOLVED. TO PREVENT THE WHEEL FROM COMING OFF, A CIRCLIP IS PLACED IN THE GROOVE OF THE WHEEL AXLE. THE WHEEL AXLES WERE ACCORDING TO SPECIFICATION. THE GROOVE OF THE RIGHT FRONT FORK AXLE WAS NOT ACCORDING TO SPECIFICATION. (B)(4).
Description of Event or Problem · 1
CUSTOMER COMPLAINT. THE WALKER HAD LOST THE RIGHT FRONT WHEEL. A SALES REPRESENTATIVE FORM ETAC COLLECTED THE WALKER AND TOOK IT TO THE MANUFACTURER'S SITE. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETAC WALKER ONO | WALKER MECHANICAL - ITJ | ITJ | ETAC SUPPLY CENTER AB | 15040105-14 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |