FDA Adverse Event
Malfunction
Summary report: N
ETAC WALKER ONO
MDR report key: 2639518
·
Received June 28, 2012
Report
- Report Number
- 3008986539-2012-00029
- Event Type
- Malfunction
- Date Received
- June 28, 2012
- Date of Event
- July 27, 2010
- Report Date
- October 8, 2010
- 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 HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CIRCLIP THAT PREVENTS THE WHEEL FROM COMING OFF HAD BEEN OVER-EXTENDED. THE WHEEL AXLES OF THE WALKER WERE ACCORDING TO SPECIFICATION. THE WHEEL AXLES WERE LUBRICATED WITH A GREASE THAT ETAC DOES NOT USE. (B)(4).
Description of Event or Problem · 1
THE RIGHT REAR WHEEL OF THE WALKER FELL OFF WHILE THE STAFF WAS BRINGING THE WALKER TO THE USER.
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 |