MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-09 for PRIDE MOBILITY PRODUCTS JAZZY ZERO TURN N/A manufactured by Pride Mobility Products.
[116698156]
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.
Patient Sequence No: 1, Text Type: N, H10
[116698157]
Alleges consumer was turning in scooter and the wheel came off the hub cap causing consumer to flip and fall off of scooter.
Patient Sequence No: 1, Text Type: D, B5
[133974954]
The device was returned and evaluated. The evaluation concluded that there was an unknown excessive force to the wheel.
Patient Sequence No: 1, Text Type: N, H10
[133974955]
Alleges consumer was turning in scooter and the wheel came off the hub cap causing consumer to flip and fall off of scooter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2018-00113 |
| MDR Report Key | 7770287 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-09 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-07 |
| Device Manufacturer Date | 2017-12-24 |
| Date Added to Maude | 2018-08-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS KELLY LIVINGSTON |
| Manufacturer Street | 401 YORK AVE |
| Manufacturer City | DURYEA PA 18642 |
| Manufacturer Country | US |
| Manufacturer Postal | 18642 |
| Manufacturer Phone | 5706024056 |
| Manufacturer G1 | N/A |
| Manufacturer Street | N/A N/A |
| Manufacturer City | N/A |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIDE MOBILITY PRODUCTS |
| Generic Name | MOTORIZED THREE-WHEELED VEHICLE |
| Product Code | INI |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-11-09 |
| Model Number | JAZZY ZERO TURN |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIDE MOBILITY PRODUCTS |
| Manufacturer Address | 401 YORK AVE DURYEA PA 18642 US 18642 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-09 |