MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for DRIVE MEDICAL 795BU manufactured by Unknown.
[79646086]
(b)(4) has received a medwatch report #mw5067290 from fda regarding an incident involving a transport chair imported by drive devilbiss healthcare: daughter reported that her mother had alzheimer's. When her mother reached out to retrieve something from a store shelf and the chair tilted forward and dumped her mother on the floor. Patient repeated the same action five (5) minutes later and fell again. Per the daughter, her father had similar incident one (1) year ago when he reached out for the car door handle. The patient was originally reported as seriously injured from the second fall. However, upon clarification with the initial reporter, her mother did not sustain any injuries or need to seek medical attention. There was no report of anything broken or structurally wrong with the alleged product. The alleged product is enroute being returned to drive for evaluation. We are unable to identify the device manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00020 |
| MDR Report Key | 6701657 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-01-14 |
| Date Facility Aware | 2017-01-30 |
| Date Added to Maude | 2017-07-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 MEDICAL |
| Generic Name | CHAIR WITH CASTERS |
| Product Code | INM |
| Date Received | 2017-07-11 |
| Model Number | 795BU |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-11 |