MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for DRIVE ZOOME FLEX manufactured by Dongguan Prestige Sporting Goods Co Ltd.
[117420683]
Drive devilbiss is the initial importer of the device which is a power mobility scooter. There was no product issue. The end-user was traveling through a doorway when the door swung back and knocked her off the scooter. The scooter ran over her feet. Patient was taken to (b)(6) hospital where she was diagnosed with fractured back and torn ligaments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00042 |
| MDR Report Key | 7791450 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-06-13 |
| Date Facility Aware | 2018-07-20 |
| Report Date | 2018-08-16 |
| Date Reported to FDA | 2018-08-16 |
| Date Reported to Mfgr | 2018-08-19 |
| Date Added to Maude | 2018-08-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | VEHICLE, MOTORIZED 3-WHEELED |
| Product Code | INI |
| Date Received | 2018-08-16 |
| Model Number | ZOOME FLEX |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DONGGUAN PRESTIGE SPORTING GOODS CO LTD |
| Manufacturer Address | 3RD INDUSTRY DISTRICT QIAOTOU AREA HOUJIE TOWN DONGGUAN, GUANGDONG 523950 CH 523950 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-08-16 |