MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for WINCO RECLINER INVERNESS 24-HOUR 6420 manufactured by Winco Mfg Llc.
[110212316]
The pt was sitting in the recliner and attempted to stand by pushing himself up on the arms of the recliner. The side arm unexpectedly swung open and he fell, fracturing his hip. He required transfer to a tertiary care facility and hip surgery. The side arm had not been opened or used at all during this pt's stay by staff or the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077640 |
| MDR Report Key | 7568927 |
| Date Received | 2018-06-04 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-05-08 |
| Date Added to Maude | 2018-06-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WINCO RECLINER |
| Generic Name | TREATMENT RECLINER WITH SWING-ARM FEATURE |
| Product Code | FRJ |
| Date Received | 2018-06-04 |
| Model Number | INVERNESS 24-HOUR |
| Catalog Number | 6420 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG LLC |
| Manufacturer Address | 5516 SOUTHWEST 1ST LANE OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-06-04 |