MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-11-01 for MIGHTY REST SINGLE BAR TRAPEZE manufactured by Raye's, Inc..
[4001862]
Pt's daughter reported that she was standing at the foot of her father's bed, with the frame of the single bar trapeze overhead. She further reported that she was struck on her head by part of the frame and that she was unconscious for about 5-10 seconds, suffering a bump on her head. The facility offered urgent care services to the pt's daughter, but she refused treatment. The pt indicated that the support frame of the trapeze had been moved out of its proper location due to location of the ceiling lift above the support frame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931307-2013-00001 |
| MDR Report Key | 3477124 |
| Report Source | 08 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-10-31 |
| Date of Event | 2013-06-26 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ERIC BOSS, PRODUCTION MGR |
| Manufacturer Street | 500 COMMERCE PARKWAY |
| Manufacturer City | HAYS KS 67601 |
| Manufacturer Country | US |
| Manufacturer Postal | 67601 |
| Manufacturer Phone | 8005376454 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIGHTY REST SINGLE BAR TRAPEZE |
| Generic Name | SINGLE BAR TRAPEZE |
| Product Code | FMR |
| Date Received | 2013-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAYE'S, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-01 |