MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for DRIVE DEVILVISS WHEELCHAIR BLS24FBD-SF manufactured by Drive Devilbiss Healthcare / Medical Depot.
[63212663]
Patient placed hands around seat frame of wheelchair to steady himself as he sat down in the wheelchair. When his weight came down on the seat, the seat dropped approximately 1/2 to 1 inch pinching his fingers under the wheelchair seat. He automatically pulled his hand from the trapped position when the fifth digit, on the palmar side of hand, was lacerated on an exposed screw. This screw was used to secure the seat fabric to the seat frame. The seat is on a sliding mechanism which allows the wheelchair to be folded for storage. When the chair was opened, the sliding mechanism did not slide to the full down position which allowed the wheelchair seat to drop when the patient sat on the seat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066838 |
| MDR Report Key | 6198011 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-12-01 |
| Date Added to Maude | 2016-12-22 |
| 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 |
| 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 DEVILVISS WHEELCHAIR |
| Generic Name | WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2016-12-20 |
| Model Number | BLS24FBD-SF |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRIVE DEVILBISS HEALTHCARE / MEDICAL DEPOT |
| Manufacturer Address | PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-20 |