MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-03-07 for WINCO 655A manufactured by Winco Mfg, Llc.
[1957546]
Pt was standing while receiving a blood pressure check ast a dialysis center. As the pt prepared to sit in the chair, she braced herself with the arms of the chair when the right drop-arm of the chair collapsed, pinching her right index finger, resulting in a laceration that required stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1027229-2011-00001 |
| MDR Report Key | 2021917 |
| Report Source | 08 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-03-07 |
| Date of Event | 2011-02-28 |
| Date Mfgr Received | 2011-03-01 |
| Date Added to Maude | 2011-04-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5516 SW FIRST LANE |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal | 34474 |
| Manufacturer Phone | 8002373377 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINCO |
| Generic Name | DROP ARM CARE CLINER |
| Product Code | FRJ |
| Date Received | 2011-03-07 |
| Model Number | 655A |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG, LLC |
| Manufacturer Address | OCALA FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-07 |