FDA Adverse Event
Other
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2100375
·
Received May 12, 2011
Report
- Report Number
- 1525712-2011-00188
- Event Type
- Other
- Date Received
- May 12, 2011
- Report Date
- May 10, 2011
- Manufacturer
- INVACARE
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR RECEIVED INFO THAT THE CONSUMER WAS DOING A RIGHT TRANSFER AND ALLEGEDLY CUT THEIR LEG ON THE UPPER SUPPORT OF THE LEGREST. CURRENT USER GUIDE COVERS PROPER TRANSFER METHODS. NO MALFUNCTION CONFIRMED. MDR FILED BASED ON ALLEGED SHARP EDGE.
Description of Event or Problem · 1
THE CONSUMER ALLEGES HE CUT HIS LEG ON A PIECE OF METAL THAT IS EXPOSED ON THE TOP OF THE UPPER SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |