FDA Adverse Event
Injury
Summary report: N
ACTION
MDR report key: 317676
·
Received February 22, 2001
Report
- Report Number
- 1525712-2001-00013
- Event Type
- Injury
- Date Received
- February 22, 2001
- Date of Event
- January 15, 2001
- Report Date
- February 13, 2001
- Manufacturer
- INVACARE CORP
- Product Code
- IOR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MFR RECEIVED A REPORT FROM A DEALER THAT THE END USER ALLEGEDLY FELL OUT OF THE CHAIR AND BROKE MULTIPLE TEETH WHEN THE SEATING SYSTEM CAME LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6912 | ACTION | MECHANICAL WHEELCHAIR | IOR | INVACARE CORP | ALLEGRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |