MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-20 for PRIDE MOBILITY PRODUCTS JAZZY PASSPORT N/A manufactured by Pride Mobility Products.
[176226415]
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.
Patient Sequence No: 1, Text Type: N, H10
[176226416]
Consumer's mother alleges while traveling in (b)(6) the unit allegedly tipped backwards causing the consumer to hit his head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2020-00009 |
| MDR Report Key | 9607188 |
| Report Source | CONSUMER |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2020-01-20 |
| 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 | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-01-20 |
| Model Number | JAZZY PASSPORT |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-20 |