MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-08 for HILL-ROM P9095 manufactured by Hill-rom.
[3499439]
Visitor sitting in recliner chair with footrest elevated. While readjusting her position with knees bent and pushing up with her feet, the footrest collapsed and she fell out of the chair. Visitor taken to the emergency dept for eval and medical treatment. Cervical fracture diagnosed, therefore, visitor admitted to the hospital for medical management. Chair evaluated by hill-rom tech. Voluntary smda report submitted to mfr on (b)(4) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030192 |
| MDR Report Key | 3118124 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-05-07 |
| Date of Event | 2013-04-04 |
| Date Added to Maude | 2013-05-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HILL-ROM |
| Generic Name | BARIATRIC RECLINER CHAIR |
| Product Code | FRJ |
| Date Received | 2013-05-08 |
| Model Number | P9095 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-05-08 |