MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-17 for WINCO 5271 manufactured by Winco Mfg Llc.
[1744296]
Pt's sock was removed from left foot to find pooled blood and a deep gash to the top of the foot, tendons exposed. Further inspection revealed another gash to left calf. Event was not witnessed but it is assumed that the pt got their leg caught in the mechanism of the chair because the apron was loose on the chair.
Patient Sequence No: 1, Text Type: D, B5
[8809065]
Winco made initial contact with the reporting facility on (b)(4) 2010. We received a reply phone call from the reporting facility on (b)(4) 2010 which provided updated contact info and when a reply could be expected. The reporting facility contacted winco on (b)(4) 2010 to verify that the injury to the pt was not witnessed and it was assumed that the pt's leg was caught in the mechanism of the chair. They also stated that the chair had been quarantined. All available info indicates that this event is the result of product misuse and there is no evidence of any malfunction of the chair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2010-00002 |
| MDR Report Key | 1938169 |
| Report Source | 05,06 |
| Date Received | 2010-12-17 |
| Date of Report | 2010-12-17 |
| Date of Event | 2010-12-02 |
| Date Mfgr Received | 2010-12-10 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2010-12-29 |
| 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 Street | 5516 S.W. FIRST LANE |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal | 34474 |
| Manufacturer Phone | 3528542929 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINCO |
| Generic Name | DROP ARM CONVALESCENT RECLINER |
| Product Code | FRJ |
| Date Received | 2010-12-17 |
| Model Number | 5271 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG LLC |
| Manufacturer Address | 5516 S.W. FIRST LANE OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-17 |