FDA Adverse Event
Malfunction
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 16983021
·
Received May 23, 2023
Report
- Report Number
- 2530130-2023-00052
- Event Type
- Malfunction
- Date Received
- May 23, 2023
- Date of Event
- May 18, 2023
- Report Date
- May 2, 2024
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- UDI-DI
- 00606509200059
- PMA / PMN Number
- K143383
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CUSTOMER ABUSE.
Additional Manufacturer Narrative · 0
THE DEVICE HAS NOT YET BEEN MADE AVAILABLE FOR EVALUATION. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
Description of Event or Problem · 0
TECH ALLEGES CONSUMER WAS USING MAGNETIC CHARGER PORT ON JS AND FLAMES ALLEGEDLY "SHOT OUT OF THE PORT"- PROVIDER ALLEGES WHEN VISUALLY INSPECTING, THERE WERE ALLEGELDY BURNT CONNECTIONS AND DISCOLORATION THROUGHOUT.
Description of Event or Problem · 0
TECH ALLEGES CONSUMER WAS USING MAGNETIC CHARGER PORT ON JS AND FLAMES ALLEGEDLY "SHOT OUT OF THE PORT"- PROVIDER ALLEGES WHEN VISUALLY INSPECTING, THERE WERE ALLEGEDLY BURNT CONNECTIONS AND DISCOLORATION THROUGHOUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1410821 | PRIDE MOBILITY PRODUCTS | WHEELCHAIR, POWERED | ITI | PRIDE MOBILITY PRODUCTS | Q6 EDGE HD (ILEVEL) | N/A | 00606509200059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |