FDA Adverse Event
Other
Summary report: N
CHAIRMAN
MDR report key: 411156
·
Received August 16, 2002
Report
- Report Number
- 1221084-2002-00007
- Event Type
- Other
- Date Received
- August 16, 2002
- Report Date
- August 13, 2002
- Manufacturer
- PERMOBIL AB
- Product Code
- ITI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER WAS LEANING FORWARD ON THE ARM RESTS OF WHEELCHAIR SEAT. THE ARM RESTS "LET GO" AND PT FELL OUT OF THE SEAT. THE "ARM RAIL" THAT PROVIDES SUPPORT TO THE ARM RESTS IS REPORTED TO HAVE BROKEN AT A WELD, WHICH IS REPORTED TO HAVE BEEN REPAIRED LOCALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHAIRMAN | POWERED WHEELCHAIR | ITI | PERMOBIL AB | CHAIRMAN 2K | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |