MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-25 for ROMEDIC MINI LIFT 200 manufactured by Handicare Usa Inc..
[41483692]
Employees were assisting a resident out of a shower chair using a sit to stand lift (minilift 200). The weld on the lift leg broke and the lift began to fall over, the employees lowered the resident and lift to the floor and one of the employees was struck in the back by the lift.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061305 |
| MDR Report Key | 5532346 |
| Date Received | 2016-03-25 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-03-01 |
| Date Added to Maude | 2016-03-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ROMEDIC MINI LIFT 200 |
| Generic Name | SIT TO STAND LIFT |
| Product Code | FMR |
| Date Received | 2016-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE USA INC. |
| Manufacturer Address | 2201 HANGAR PLACE ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-03-25 |