MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for INVACARE STAND ASSIST SLING manufactured by .
[96046012]
Strap on stand up lift came loose and resident fell, fx left humerus during transfer. Resident being transferred with sit to stand lift to toilet when the strap on stand assist sling came loose and buckle broke off. Replaced and old sling removed immediately. Lifts and slings checked by maintenance monthly, last date checked - (b)(6) 2017, due for check on (b)(6) , 2017. Replaced sling due to malfunctioned. Invacare premier sling stand assist. Ino. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7150672 |
| MDR Report Key | 7150672 |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-12-20 |
| Date Facility Aware | 2017-12-20 |
| Report Date | 2017-12-21 |
| Date Reported to FDA | 2017-12-21 |
| Date Added to Maude | 2017-12-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 STAND ASSIST SLING |
| Generic Name | INVACARE STAND ASSIST SLING |
| Product Code | IKX |
| Date Received | 2017-12-21 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-12-21 |