MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-12 for LUMEX manufactured by Lumex, Inc..
[17512497]
Per report from user facility administrator:patient discovered by nursing aide at 0010 monday. Patient lying with feet out of bed, buttock on floor, head was between bottom of side rail and mattress. Patient facing up. Patient strangled on underside of bed rail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32574-1994-00004 |
| MDR Report Key | 13622 |
| Date Received | 1994-04-12 |
| Date of Report | 1994-02-22 |
| Date of Event | 1994-02-21 |
| Date Facility Aware | 1994-02-21 |
| Report Date | 1994-02-22 |
| Date Reported to FDA | 1994-02-22 |
| Date Reported to Mfgr | 1994-02-22 |
| Date Added to Maude | 1994-05-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMEX |
| Generic Name | TELESCOPING SIDE RAIL |
| Product Code | FNK |
| Date Received | 1994-04-12 |
| ID Number | 5087-50-00 (RED LINE CAT. #) |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13620 |
| Manufacturer | LUMEX, INC. |
| Manufacturer Address | 100 SPENCE STREET BAY SHORE NY 11706 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1994-04-12 |