FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 3780964
·
Received April 30, 2014
Report
- Report Number
- 2530130-2014-00032
- Event Type
- Injury
- Date Received
- April 30, 2014
- Report Date
- April 28, 2014
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- UNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DATE OF INCIDENT, MODEL NUMBER, SERIAL NUMBER AND DATE OF MANUFACTURE HAVE NOT BEEN PROVIDED AT THIS TIME. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED. DEVICE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER ALLEGES HE WASN'T TRAINED ON USE AND FELL FROM UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260425 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | UNKNOWN | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |