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 BOBCAT X3 manufactured by .
[119545856]
Drive medical received a notice from the daughter of the end user regarding an incident involving a scooter that drive medical imports and distributes. As the end user was already down the ramp which he built to get in and out of the house, the scooter flipped over and landed on top of him. As a result, he suffered a crack vertebrae. This report is based on information provided by the end user and his daughter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616873-2016-00001 |
| MDR Report Key | 7855891 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-06 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-04-21 |
| 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. 225, YUAN-PIER ST. HSIN CHU CITY, HSINCHU |
| Manufacturer City | MUNICIPALITY, 30093 |
| Manufacturer Country | TW |
| Manufacturer Postal | 30093 |
| Manufacturer G1 | WU'S TECH |
| Manufacturer Street | NO. 225, YUAN-PIER ST. HSIN CHU CITY |
| Manufacturer City | TW-HSQ, 30093 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 30093 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | MOTORIZED 3 WHEELVEHICLE |
| Product Code | INI |
| Date Received | 2018-09-07 |
| Model Number | BOBCAT X3 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-07 |