MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for EVEREST & JENNINGS IOSO83WC0319 manufactured by Graham-field.
[117443172]
Am, an assisted living facility resident, fell forward out of the wheelchair, landing on her face. Was sent to hosp where she was found to have sustained a fractured nose, and lacerations to the nose and upper lip, which required sutures. She was returned to the alf and demonstrated decline over the next days, dying on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7788233 |
| MDR Report Key | 7788233 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-06-11 |
| Date Facility Aware | 2018-06-11 |
| Report Date | 2018-08-14 |
| Date Reported to FDA | 2018-08-14 |
| Date Reported to Mfgr | 2018-08-14 |
| Date Added to Maude | 2018-08-16 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | EVEREST & JENNINGS |
| Generic Name | COMPANION CHAIR |
| Product Code | IML |
| Date Received | 2018-08-14 |
| Model Number | IOSO83WC0319 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRAHAM-FIELD |
| Manufacturer Address | ONE GRAHAM FIELD WAY ATLANTA GA 30340 US 30340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-08-14 |