MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-16 for CONVALESCENT RECLINER 5241 manufactured by Winco, Inc..
[3853533]
At approx 4:00pm on tuesday, (b)(6) 2013, winco's customer care manager, (b)(4) received a call from (b)(6) with nursing home and rehab center. Ms. (b)(6) informed winco that a patient was injured while using 524 chair (s/n (b)(4)) on saturday, (b)(6) 2013, at approx 6:00pm. Ms. (b)(6) stated that the pt wedged his leg between the seat and arm of the chair for no apparent reason. When the patient attempted to remove his leg he inadvertently broke the sidearm panel. The break in the side arm panel then lead to lacerations on his leg while attempting to get out of the chair. After unsuccessful attempts by the staff to remove the patient from the chair the concord nursing facility called the fire department at which time he was extracted from the chair and transported to the hospital. Ms. Rosemont contacted the patient's wife and was advised that he had no broken bones and was being treated for the lacerations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1027229-2013-00002 |
| MDR Report Key | 3445213 |
| Report Source | 06 |
| Date Received | 2013-10-16 |
| Date of Report | 2013-10-16 |
| Date of Event | 2013-10-12 |
| Date Mfgr Received | 2013-10-15 |
| Date Added to Maude | 2013-12-04 |
| 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 Contact | GEORGE ANELLO, QUALITY MGR |
| Manufacturer Street | 5516 S.W. FIRST LN. |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal | 34474 |
| Manufacturer Phone | 3528542929 |
| Manufacturer G1 | WINCO, INC. |
| Manufacturer Street | 5516 S.W. FIRST LN. |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34474 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVALESCENT RECLINER |
| Generic Name | 524 CONVALESCENT RECLINER |
| Product Code | FRJ |
| Date Received | 2013-10-16 |
| Model Number | 5241 |
| Catalog Number | 5241 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO, INC. |
| Manufacturer Address | 5516 S.W. FIRST LN. OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-10-16 |