MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for DRIVE TS19 manufactured by A & I.
[140548683]
(b)(4) is the initial importer of the device which is a transport chair. The end-user sat in the transport chair. The brake was engaged; the device was locked. The device is meant to be pushed by an attendant. (b)(6) tried to turn the chair. It went backwards and flipped over. He hit his head on the pavement. He was transported to the hospital by ems. Further tests revealed a sprained shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00017 |
| MDR Report Key | 8471389 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-18 |
| Date Facility Aware | 2019-03-20 |
| Report Date | 2019-04-01 |
| Date Reported to FDA | 2019-04-01 |
| Date Reported to Mfgr | 2019-04-02 |
| Date Added to Maude | 2019-04-01 |
| 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 | TRANSPORT CHAIR |
| Product Code | INM |
| Date Received | 2019-04-01 |
| Model Number | TS19 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A & I |
| Manufacturer Address | LIAN DU INDUSTRY PARK LE LIU TOWN SHUNDE DISTRICT, FOSHAN CIT CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-01 |