FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 13230975
·
Received January 11, 2022
Report
- Report Number
- 2530130-2022-00004
- Event Type
- Injury
- Date Received
- January 11, 2022
- Date of Event
- August 4, 2021
- Report Date
- January 11, 2022
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- UKN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION. SHOULD FURTHER INFORMATION OF THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE ISSUED.
Description of Event or Problem · 0
RECEIVED LETTER FROM ATTORNEY ALLEGING ON (B)(6) 2021, A WHEELCHAIR BEING OPERATED BY MS. (B)(6) MALFUNCTIONED CAUSING A FIRE IN HER RENTED APARTMENT WHICH RESULTED IN DAMAGE TO HER AND HER PROPERTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 686643 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | UKN | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization |