MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-15 for DRIVE HIGH BACK WHEELCHAIR 4S1301120563 manufactured by Drive.
[52504835]
Pt was sitting in a high back reclining back wheelchair. Was seen by therapy, nursing staff, pt was fine in wheelchair. As pt was wheeling by the nurse area, the back of the wheelchair released, reclining all the way back and resident went backwards in the chair, hitting her head. Dates of use: 3 years. Diagnosis or reason for use: multiple sclerosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064161 |
| MDR Report Key | 5885415 |
| Date Received | 2016-08-15 |
| Date of Report | 2016-08-15 |
| Date of Event | 2016-08-13 |
| Date Added to Maude | 2016-08-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | DRIVE HIGH BACK WHEELCHAIR |
| Generic Name | HIGH BACK WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2016-08-15 |
| Model Number | 4S1301120563 |
| Lot Number | SSP18RBDDA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRIVE |
| Manufacturer Address | PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-08-15 |