MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-08 for WINCO MFG, LLC VARIOUS manufactured by Winco Mfg, Llc.
[3362673]
Winco mfg, llc provided clinical recliner chairs. The chairs are less then 6 months old and are mechanically breaking. In the scissor mechanisms, the screws are falling out allowing the chairs to lock into a recline position and will not allow pts to sit up right. Danger in low blood pressure, restraint from existing chair and mechanically unstable. Dates of use: (b)(6) 2012 - (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029716 |
| MDR Report Key | 3057232 |
| Date Received | 2013-04-08 |
| Date of Report | 2013-04-08 |
| Date of Event | 2012-12-20 |
| Date Added to Maude | 2013-04-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | WINCO MFG, LLC |
| Generic Name | RECLINER CHAIR, 300# |
| Product Code | FRJ |
| Date Received | 2013-04-08 |
| Model Number | VARIOUS |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG, LLC |
| Manufacturer Address | 5516 SW 1ST AVE OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-08 |