MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for BEST LIFT (PL400H) HOYER LIFT manufactured by Bestcare, Llc.
[180339486]
Pt being lifted from wheelchair to bed with a best lift (pl400h) when the head of the arm came off, causing the decedent to fall to the floor. Pt transported to local hosp with a left ramus fx and left tibia/fibula fx. He expired the same day. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093097 |
| MDR Report Key | 9732651 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-15 |
| Date of Event | 2020-02-14 |
| Date Added to Maude | 2020-02-20 |
| 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 | 3 |
| Brand Name | BEST LIFT (PL400H) HOYER LIFT |
| Generic Name | LIFT, PATIENT, NON-AC POWERED |
| Product Code | FSA |
| Date Received | 2020-02-19 |
| Model Number | PL400H |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BESTCARE, LLC |
| Manufacturer Address | NORCROSS GA 30071 US 30071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2020-02-19 |