MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-02-17 for LIFECARE RECLINER 5851 manufactured by Winco Mfg Llc.
[4203649]
At appropriately 12:30 pm, monday (b)(6) 2014, winco received a call from (b)(6), stating that her daughter fell from her winco life-care recliner. (b)(6) stated that shortly after leaving the room to attend to the other children, she heard a call from her daughter. When (b)(6) re-enter the room she noticed that her daughter who sitting in the recliner the entire day and who has cerebral palsy was now on the floor. She stated that she didn't know how she fell out of the recliner but was guessing that her daughter climbed over the table. She also stated that the table was pushed off of the recliner and wasn't sure how it came off. The daughter was transported to the hosp where she was diagnosed with a concussion. (b)(6) also stated that her daughter's seizure started up again since the fall, after a 2 year lapse. Daughter was not admitted to hosp.
Patient Sequence No: 1, Text Type: D, B5
[11656396]
Caregiver was advised that the table was not to be used as a restraint nor was the pt to be left alone in the recliner.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2014-00001 |
| MDR Report Key | 3637014 |
| Report Source | 00 |
| Date Received | 2014-02-17 |
| Date of Report | 2014-02-17 |
| Date of Event | 2014-02-16 |
| Date Mfgr Received | 2014-02-17 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2014-02-21 |
| 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 | GREORGE ANELLO |
| 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 | LIFECARE RECLINER |
| Generic Name | GERIATRIC RECLINER |
| Product Code | FRJ |
| Date Received | 2014-02-17 |
| Model Number | 5851 |
| Catalog Number | 5851 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization | 2014-02-17 |