MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for INVACARE R111 manufactured by Invacare Corp..
[109451464]
Resident was being transferred when sling tore causing resident to fall to floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077448 |
| MDR Report Key | 7544235 |
| Date Received | 2018-05-24 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-09-11 |
| Date Added to Maude | 2018-05-25 |
| 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 | INVACARE |
| Generic Name | INVACARE HOYER SLING |
| Product Code | FNG |
| Date Received | 2018-05-24 |
| Model Number | R111 |
| Catalog Number | R111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORP. |
| Manufacturer Address | 39400 TAYLOR PARKWAY NORTH RIDGEVILLE OH 44039 US 44039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-05-24 |