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 PHOENIXHD3 manufactured by .
[119639491]
(b)(4) received notice regarding the incident from the provider, involving a scooter, a product imported and distributed by (b)(4). The enduser was turning off the driveway and onto the sidewalk when she hit a brick on the left hand side of the scooter, which allegedly caused the scooter to land on top of her and hurt right arm. She was also having trouble breathing and was coughing up blood. She went to the hospital and a x-ray was taken. Drive has been reaching out to the enduser for product information to further investigate the complaint, however, this information is still not available at this time. This report is based on the information that was provided by the provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616873-2017-00001 |
| MDR Report Key | 7856604 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-07 |
| Date Mfgr Received | 2017-03-10 |
| 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 (VIETNAM) CO., LTD. |
| Manufacturer Street | NO.31, VSIP II, ROAD 6 HOA PHU WARD TDM CITY |
| Manufacturer City | BINH DUONG PROVINCE, BINH 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 WHEEL VEHICLE |
| Product Code | INI |
| Date Received | 2018-09-07 |
| Model Number | PHOENIXHD3 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |