MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-09-07 for DRIVE manufactured by Wu's Tech.
[119549987]
Drive devilbiss healthcare received notification from a patient using a scooter that drive devilbiss healthcare imports and distributes. The patient was using the scooter in her kitchen, she attempted to turn left and the unit allegedly tipped over. She claims to have broken her shoulder, sprained her neck, and also hurt her head. She went to her physician to get an x-ray which showed a shoulder injury. Once she fell, the steering wheel allegedly broke as well. The patient requested to have the broken unit picked up from her home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616873-2016-00002 |
| MDR Report Key | 7855889 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-07 |
| Date Mfgr Received | 2016-08-08 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2018-09-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR TIM KAO |
| Manufacturer Street | NO.31, ROAD 6, VSIP II HOA PHU WARD |
| Manufacturer City | THU DAU MOT TOWN, BIHN DUONG, |
| Manufacturer Country | VM |
| Manufacturer G1 | WU'S TECH |
| Manufacturer Street | NO.31, ROAD 6, VSIP II HOA PHU WARD |
| Manufacturer City | THU DAU MOT TOWN, BIHN DUONG, |
| Manufacturer Country | VM |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | MOTORIZED 3-WHEELED VEHICLE, PRODUCT CODE: INI |
| Product Code | INI |
| Date Received | 2018-09-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WU'S TECH |
| Manufacturer Address | NO.31, ROAD 6, VSIP II, HOA PHU WARD THU DAU MOT TOWN,, BIHN DUONG VM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |