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 |