FDA Adverse Event
Injury
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3180711
·
Received June 20, 2013
Report
- Report Number
- 1525712-2013-04841
- Event Type
- Injury
- Date Received
- June 20, 2013
- Report Date
- May 23, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
MDR DECISION DATE: (B)(4). NO MALFUNCTION ALLEGED. FACILITY ALLEGES USER MAY HAVE NOT BEEN STRAPPED IN THE UNIT PROPERLY WHEN THEY FELL OUT OF UNIT. DISLOCATED SHOULDER AND HAS BRUISE ON SIDE OF BODY.
Description of Event or Problem · 1
FACILITY ALLEGES USER MAY HAVE NOT BEEN STRAPPED IN THE UNIT PROPERLY WHEN THEY FELL OUT OF UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279955 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE TAYLOR STREET | RPL450-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |