MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for MATTRESS manufactured by Invacare.
[129312081]
On call rn received call stating pt had passed and daughter was hysterical. When ocrn arrived at the home, pt was deceased and kneeling on the left side of the bed with her head entrapped between the bed frame and half side rail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8128958 |
| MDR Report Key | 8128958 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-11-26 |
| Date Facility Aware | 2018-11-26 |
| Report Date | 2018-11-30 |
| Date Reported to FDA | 2018-11-30 |
| Date Reported to Mfgr | 2018-11-30 |
| Date Added to Maude | 2018-12-04 |
| 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 | MATTRESS |
| Generic Name | INVACARE INNER SPRING MATTRESS |
| Product Code | FMW |
| Date Received | 2018-11-30 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE |
| Manufacturer Address | 1 INVACARE WAY ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-11-30 |