MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2010-09-27 for WINCO 5560 manufactured by Winco Mfg., Llc.
[15537424]
A male resident at (b)(6) health care in (b)(6) was in the chair in a reclined position with his hands by his side. The attendant attempted to raise the resident, and as the attendant was doing that, the resident placed his hands between the seat and the side panel and got his fingers caught in the mechanism. Resident's fingers were cut, he was transported to the hospital and received stitches.
Patient Sequence No: 1, Text Type: D, B5
[15990332]
Safety shields were ordered by the distributor and sent to the user facility. Instructions for installation of the safety shields were also sent to the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2010-00001 |
| MDR Report Key | 1849485 |
| Report Source | 06,08 |
| Date Received | 2010-09-27 |
| Date of Report | 2010-09-22 |
| Date of Event | 2010-09-09 |
| Date Mfgr Received | 2010-09-10 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2010-10-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5516 SW 1ST 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 | COMFORT CARE PREMIER RECLINER |
| Product Code | FRJ |
| Date Received | 2010-09-27 |
| Model Number | 5560 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG., LLC |
| Manufacturer Address | 5516 SW 1ST LANE OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-09-27 |