FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 3922804
·
Received July 9, 2014
Report
- Report Number
- 2530130-2014-00052
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 25, 2014
- Report Date
- September 5, 2014
- 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
Additional Manufacturer Narrative · 1
FAILURE TO FOLLOW JOYSTICK BUSS CABLE ROUTING INSTRUCTIONS.
Description of Event or Problem · 1
DEALER REPORTED CUSTOMER IS RUNNING OVER HER CHARGER CORD CAUSING IT TO FRAY. SHE REPORTED SHE WAS HURT.
Description of Event or Problem · 1
DEALER REPORTED CUSTOMER IS RUNNING OVER HER CHARGER CORD CAUSING IT TO FRAY. SHE REPORTED SHE WAS HURT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399642 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | J614HD | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |