FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 6807701
·
Received August 21, 2017
Report
- Report Number
- 2530130-2017-00108
- Event Type
- Injury
- Date Received
- August 21, 2017
- Date of Event
- June 30, 2017
- Report Date
- January 23, 2018
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- K042612
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED AND REPAIRED BY PRIDE (B)(6). THE UNIT IS WORKING PROPERLY.
Additional Manufacturer Narrative · 1
THE DEVICE EVALUATION HAS NOT BEEN COMPLETED AT THIS TIME. ONCE EVALUATION IS CONDUCTED, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
Description of Event or Problem · 1
ALLEGES CUSTOMER WAS STOPPED ON AN ISLAND WHEN USING THE CONTROLLER, THEY COMMANDED THE PWC TO GO FORWARD AND THE PWC ALLEGEDLY VEERED AND SPUN AROUND, WHICH CAUSED THE PWC TO TIP OVER, TRAPPING THE CLIENT UNDER THE CHAIR.
Description of Event or Problem · 1
ALLEGES CUSTOMER WAS STOPPED ON AN ISLAND WHEN USING THE CONTROLLER, THEY COMMANDED THE PWC TO GO FORWARD AND THE PWC ALLEGEDLY VEERED AND SPUN AROUND, WHICH CAUSED THE PWC TO TIP OVER, TRAPPING THE CLIENT UNDER THE CHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587725 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | Q6 EDGE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |