MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-03 for BAILEY FOLDING 595 * manufactured by Bailey Mfg..
[57845]
Pt was descending from 8" step using parallel bars. Bars had been checked for safety by staff for stablility before pt used the bars. Pt fell forward and landed on left hip. X-rays were negative. "uclever" pin did not engage fully into the slot. Hospital notified mfr. (yr. 1995 installed)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011619 |
| MDR Report Key | 102908 |
| Date Received | 1997-07-03 |
| Date of Report | 1997-06-24 |
| Date of Event | 1997-06-12 |
| Date Added to Maude | 1997-07-08 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAILEY FOLDING |
| Generic Name | WALL MOUNTED, PARALLED BAR |
| Product Code | IOE |
| Date Received | 1997-07-03 |
| Model Number | 595 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 101273 |
| Manufacturer | BAILEY MFG. |
| Manufacturer Address | P.O. BOX 130 LODI OH 44254 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-03 |