MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-12-17 for WINCO 527 manufactured by Winco.
[2946359]
Pt's sock was removed from left foot to find pooled blood and a deep gash to top of foot, tendons exposed. Further inspection revealed another gash to left calf. It appears pt's foot/leg were cut by the "workings" of the reclining chair in which the pt was sitting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2805608 |
| MDR Report Key | 2805608 |
| Report Source | 99 |
| Date Received | 2010-12-17 |
| Date of Report | 2010-12-07 |
| Date of Event | 2010-12-02 |
| Date Facility Aware | 2010-12-02 |
| Report Date | 2010-12-07 |
| Date Reported to Mfgr | 2010-12-07 |
| Date Added to Maude | 2012-10-31 |
| 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 |
| 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 |
| Brand Name | WINCO |
| Generic Name | RECLINING CHAIR |
| Product Code | FRJ |
| Date Received | 2010-12-17 |
| Model Number | 527 |
| ID Number | 619279 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO |
| Manufacturer Address | OCALA FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-17 |