MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for DRIVE manufactured by .
[59040784]
(b)(4) received notification from defendant's attorney of an incident involving a lap belt that (b)(4) imports and distributes. The patient was a passenger in an ambulette when a collision or near collision led to an abrupt stop, allegedly causing serious injury. The patient was sitting in a wheelchair (different brand) but using a drive lap belt at the time of the incident. A few weeks later, the patient died, allegedly due to the injuries suffered from the motor vehicle accident. The lap belt was not returned for evaluation, therefore, we are unable to identify the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00056 |
| MDR Report Key | 6075398 |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-07 |
| Date of Event | 2008-08-08 |
| Date Facility Aware | 2016-10-07 |
| Report Date | 2016-11-03 |
| Date Reported to FDA | 2016-11-03 |
| Date Added to Maude | 2016-11-03 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | LAP BELT |
| Product Code | IQB |
| Date Received | 2016-11-03 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2016-11-03 |