MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-20 for WINCO 6950 manufactured by Winco Mfg, Llc..
[14926441]
(b)(6) nursing home in (b)(6) contacted winco mfg on (b)(6) 2011 to report an incident which resulted in an injury to a patient. The patient was seated in a winco 6950 elite care cliner xl chair. The staff member left the patient unattended, and, upon returning to the room, found the patient laying face down on the floor. The patient sustained an injury to her forehead and to her lip. The patient cannot communicate and was unable to explain what had happened.
Patient Sequence No: 1, Text Type: D, B5
[15298071]
(b)(4) of winco mfg had an additional conversation with a representative of (b)(6) on (b)(6) 2011. (b)(6) stated that she did not know that the model of chair in use was not designed to lock. (b)(6) advised that the facility should purchase a long term care chair that has a locking feature. The facility did not report any defect with the chair. The facility also stated that the patient involved was known to 'scoot' while in the chair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2011-00004 |
| MDR Report Key | 2310041 |
| Report Source | 06 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-10-13 |
| Date Mfgr Received | 2011-10-13 |
| Device Manufacturer Date | 2011-03-01 |
| 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 |
| Manufacturer Phone | 8002373377 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINCO |
| Generic Name | ELITE CARE CLINER |
| Product Code | FRJ |
| Date Received | 2011-10-20 |
| Model Number | 6950 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-10-20 |