MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-25 for PRIDE MOBILITY PRODUCTS S614 ZOLAR N/A manufactured by Pride Mobility Products.
[139689640]
The "date of event" and "patient identifier" have not been provided. Should further information or the device become available, a follow-up report will then be issued.
Patient Sequence No: 1, Text Type: N, H10
[139689641]
Alleges scooter suddenly started driving/picked up speed, consumer missed a turn, and went down the stairway. Alleges consumer went down first and was injured. Alleges scooter went down after her, but got stuck halfway, and did not fall on top of consumer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2019-00028 |
| MDR Report Key | 8447810 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-21 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2019-03-25 |
| 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 | 2019-03-25 |
| Model Number | S614 ZOLAR |
| 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 | 2019-03-25 |