MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-13 for WINCO 6550 manufactured by Winco Mfg, Llc.
[2224487]
(b)(6) contacted winco mfg on (b)(6) 2011 to report an incident involving a 6550 drop arm care cliner. The facility reported that a care giver was transporting a pt to a room when the care giver wrenched their back trying to turn the chair to enter a room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1027229-2011-00003 |
| MDR Report Key | 2310631 |
| Report Source | 05,06 |
| Date Received | 2011-10-13 |
| Date of Report | 2011-10-11 |
| Date of Event | 2011-10-07 |
| Date Mfgr Received | 2011-10-07 |
| Device Manufacturer Date | 2011-09-26 |
| Date Added to Maude | 2011-10-28 |
| 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 |
| Single Use | 3 |
| 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 | 2011-10-13 |
| Model Number | 6550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG, LLC |
| Manufacturer Address | 5516 S.W. FIRST LN. OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-13 |