FDA Adverse Event
Malfunction
Summary report: N
ETAC SWIFT MOBIL
MDR report key: 2890577
·
Received November 19, 2012
Report
- Report Number
- 3008986539-2012-00074
- Event Type
- Malfunction
- Date Received
- November 19, 2012
- Date of Event
- October 5, 2012
- Report Date
- October 19, 2012
- Manufacturer
- ETAC SUPPLY CENTER AB
- Product Code
- INM
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A (ONE) FRONT CASTOR OF THE SHOWER CHAIR CAME LOOSE. PT IS SITTING IN THE CHAIR AND IS WEARING A SAFETY BELT. THE ASSISTANT MANAGES TO GET HOLD OF THE PT. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETAC SWIFT MOBIL | CHAIR, WITH CASTERS - INM | INM | ETAC SUPPLY CENTER AB | 80209412 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |