MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for DRIVE VENTURA420CS manufactured by Wu's Tech (vietnam) Co., Ltd..
[183006797]
(b)(4) is the initial importer of the device which is a power scooter. Scooter was returned and evaluated as conforming. She was "flung" forward the first time she was using the unit when she adjusted the tiller. (steering). She hit her head. The weight maximum on the unit is 400 pounds. We are filing this report per protocols because she hit her head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00018 |
| MDR Report Key | 9818597 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-23 |
| Date Facility Aware | 2020-01-27 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| 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 | POWER MOBILITY |
| Product Code | INI |
| Date Received | 2020-03-11 |
| Model Number | VENTURA420CS |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WU'S TECH (VIETNAM) CO., LTD. |
| Manufacturer Address | NO.31, VSIP II, ROAD 6, HOA PHU WARD TDM CITY BINH DUONG PROVINCE BINH DUONG, VM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |