MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-01-14 for LEATHER RESTRAINTS manufactured by .
[781189]
An extremely agitated pt was admitted through the ed in 4 point leather restraints. He was being transferred from the ed stretcher onto the inpatient bed when he arrested. They were in the process of reapplying the restraints when he coded. The user facility did not initially recognize this as reportable via medwatch. The pa dept of health and cms have both been notified. The doh conducted an investigation. The coroner did an autopsy and the cause of death was arteriosclerotic cardio- vascular disease.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 997122 |
| MDR Report Key | 997122 |
| Report Source | 99 |
| Date Received | 2008-01-14 |
| Date of Report | 2006-04-19 |
| Date of Event | 2005-10-21 |
| Date Facility Aware | 2005-10-24 |
| Report Date | 2006-04-19 |
| Date Reported to FDA | 2006-04-20 |
| Date Added to Maude | 2008-02-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LEATHER RESTRAINTS |
| Product Code | BRT |
| Date Received | 2008-01-14 |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 969179 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-01-14 |