FDA Adverse Event
Injury
Summary report: N
TILITE TRC
MDR report key: 645977
·
Received November 10, 2005
Report
- Report Number
- 3032618-2005-00001
- Event Type
- Injury
- Date Received
- November 10, 2005
- Date of Event
- March 1, 2003
- Report Date
- November 10, 2005
- Manufacturer
- TISPORT, LLC
- Product Code
- IOR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CONSUMER ALLEGES THAT THE WHEELCHAIR CAUSED THE CONSUMER TO DEVELOP DECUBITUS ULCERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TILITE TRC | 890.3850 | IOR | TISPORT, LLC | TRC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |