MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-03 for WINCO 6551 manufactured by Winco Mfg.
[2633763]
Winco mfg customer care technical specialist was participating in a conference call with (b)(6), on the afternoon of (b)(6) 2012 when, a rep from (b)(6) mentioned a pt being injured in 6551 drop arm chair. (b)(6) rep stated that the pt cut their finger while trying to get out of the chair. Winco mfg attempted to make further direct contact with (b)(6) on (b)(6). Winco was able to speak with (b)(6), on (b)(6) at 3pm. The nursing mgr confirmed that on (b)(6) 2012, an (b)(6) male pt weighing (b)(6), was attempting to get out of a 6551 drop arm chair when the left arm of the chair dropped, pinching his left middle finger and causing a cut that required two stitches. Floor mgr and maintenance personnel inspected the chair and made several attempts to force the arm to drop. No defect or damage was found with the chair. The serial number was not recorded.
Patient Sequence No: 1, Text Type: D, B5
[9845405]
The chair was not removed from service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2012-00001 |
| MDR Report Key | 2572772 |
| Report Source | 05 |
| Date Received | 2012-05-03 |
| Date of Report | 2012-05-03 |
| Date of Event | 2012-04-10 |
| Date Mfgr Received | 2012-04-27 |
| Date Added to Maude | 2012-05-15 |
| 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 LN. |
| 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 | 6551 DROP ARM CARECLINER |
| Product Code | FRJ |
| Date Received | 2012-05-03 |
| Model Number | 6551 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG |
| Manufacturer Address | OCALA FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-03 |