MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-16 for HALF LENGTH BEDRAIL 6083-50-09 manufactured by Theradyne.
[21637026]
There were no witnesses to this accident. Based on investigation, the facility concluded that the resident cut her lower leg on the half length side rail on the bottom portion of resident's bed. The side rail was in the down position, apparently, resident caught her leg on round, cyclinder portion of metal latch. The resident is confused and has very poor skin integrity. Injury required that the resident be transfewrred to hospital emergency room for sutures. Wound due to resident's skin condition was unable to be sutured. Resident as of 1/17/96 is receiving daily dressings and antibiotic treatment. Vascular surgeon evaluatedresident injuryon 1/10/96 and willcontinue to be followed as necessary. Resident may require skin graft. Based on this unsafe feature, the side rails were removed from the resident's bed prior to her return from the emergency room. All side rails with this design were removed from resident beds on january 9, 1996.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31147 |
| MDR Report Key | 31147 |
| Date Received | 1996-01-16 |
| Date of Report | 1996-01-16 |
| Date of Event | 1996-01-08 |
| Date Facility Aware | 1996-01-08 |
| Report Date | 1996-01-16 |
| Date Reported to FDA | 1996-01-16 |
| Date Added to Maude | 1996-03-15 |
| 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 | 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 | HALF LENGTH BEDRAIL |
| Generic Name | BEDRAIL |
| Product Code | FNK |
| Date Received | 1996-01-16 |
| Catalog Number | 6083-50-09 |
| Operator | PATIENT |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32217 |
| Manufacturer | THERADYNE |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-01-16 |