MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-06 for PRIDE MOBILITY PRODUCTS Q6 EDGE 3 N/A manufactured by Pride Mobility Products.
[178000971]
The "date of event" and "patient identifier" have not been provided. The device has not been made available for evaluation as of yet. Should further information or the device become available, a follow-up report will then be completed.
Patient Sequence No: 1, Text Type: N, H10
[178000972]
Provider alleges consumer had an epileptic seizure and loss consciousness causing him to allegedly drive down a small flight of stairs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2020-00020 |
| MDR Report Key | 9676902 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-03-22 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | Q6 EDGE 3 |
| 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 | 2020-02-06 |