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 BOBCATX3 manufactured by .
[119553741]
Drive devilbiss is the initial importer of the device which is a 3 wheel mobility scooter. The initial intake report noted that the wheel became stuck in a metal handicapped ramp causing the scooter to tip over. The end-user states she was going down curb to cut into the street when the unit tipped over. The handle bars went into her side causing 3 fractured ribs and a lacerated spleen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616873-2018-00001 |
| MDR Report Key | 7855894 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-04-23 |
| Device Manufacturer Date | 2018-05-14 |
| 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 THU DAU MOT TOWN |
| Manufacturer City | BIHN DUONG PROVINCE,, BINH DUON |
| Manufacturer Country | VM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | SCOOTER |
| Product Code | INI |
| Date Received | 2018-09-07 |
| Model Number | BOBCATX3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-07 |