MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-01-28 for PRIDE MOBILITY PRODUCTS SC40E GO GO ELITE TRAVELLER 3 WHEEL N/A manufactured by Pride Mobility Products.
[134181140]
The "serial #" and "device manufacture date" have not been provided. The device has not been made available for evaluation at this time. Should more information or the device become available, a follow-up report will then be issued.
Patient Sequence No: 1, Text Type: N, H10
[134181141]
Consumer was allegedly driving her scooter towards the front door of her building when the scooter allegedly began to toll backwards and she allegedly fell off the curbed walkway onto the driveway resulting in an injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2019-00004 |
| MDR Report Key | 8280854 |
| Report Source | OTHER |
| Date Received | 2019-01-28 |
| Date of Report | 2019-11-21 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2019-01-28 |
| 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 | 2019-01-28 |
| Model Number | SC40E GO GO ELITE TRAVELLER 3 WHEEL |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-01-28 |