FDA Adverse Event
Death
Summary report: N
PRIDE
MDR report key: 1349826
·
Received March 23, 2009
Report
- Report Number
- 2530130-2009-00010
- Event Type
- Death
- Date Received
- March 23, 2009
- Date of Event
- March 6, 2009
- Report Date
- March 20, 2009
- Manufacturer
- PRIDE MOBILITY PRODUCTS CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE AND SCENE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. IT HAS NOT YET BEEN DETERMINED IF PRIDE'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. PRIDE IS REPORTING THIS INCIDENT BASED ON THE SEVERITY OF THE COMPLAINT.
Description of Event or Problem · 1
RECEIVED A LETTER FROM AN ATTORNEY ALLEGING A FIRE OCCURRED IN A HOME WHERE A PRIDE POWERCHAIR WAS LOCATED. THE END USER PASSED AWAY AS A RESULT OF INJURIES SUSTAINED IN THE FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE | POWERCHAIR | ITI | PRIDE MOBILITY PRODUCTS CORP. | SELECT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death |