MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-10-02 for PRIDE MOBILITY PRODUCTS SC40X GO GO ULTRA X 3 WHEEL N/A manufactured by Pride Mobility Products.
[122333320]
The "date of event" and "patient identifier" have not been provided. The device has not been made available for evaluation at this time. Should the device or further information become available, a follow-up report will then be issued.
Patient Sequence No: 1, Text Type: N, H10
[122333321]
Alleges end user backed off a curb and sustained injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2018-00138 |
| MDR Report Key | 7926049 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-01 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2016-11-05 |
| Date Added to Maude | 2018-10-02 |
| 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 | 2018-10-02 |
| Returned To Mfg | 2019-06-05 |
| Model Number | SC40X GO GO ULTRA X 3 WHEEL |
| 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 | 2018-10-02 |