MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-05-08 for HOYER MANUAL LIFT HML400 manufactured by Apex Healthcare Mfg Inc.
[20145739]
It was reported to the manufacturer by plaintiff's counsel, per the received documents, the plaintiff, who was the caregiver, alleges that she was attempting to use the lift to transfer the home care patient from his bed to his wheelchair. While the home care patient was being lifted, the pneumatic arm suddenly failed and began to plunge toward the ground. In an attempt to prevent harm to the home care patient, the caregiver grabbed the weight bearing chains securing the arm to keep the patient from crashing to the ground. The chains and patient spun, twisting and contorting the caregiver's arms, neck and spine. Numerous requests to counsel have been made to receive additional information and details related to this alleged incident report with no response from the counsel. Complaint #(b)(4) was entered into our system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2015-00012 |
| MDR Report Key | 4765685 |
| Report Source | 00 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-05-07 |
| Date of Event | 2011-04-10 |
| Date Facility Aware | 2011-04-10 |
| Report Date | 2015-05-07 |
| Date Reported to FDA | 2015-05-07 |
| Date Reported to Mfgr | 2015-05-07 |
| Date Mfgr Received | 2015-04-07 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2015-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN RD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER MANUAL LIFT |
| Generic Name | MANUAL PATIENT LIFT |
| Product Code | FNG |
| Date Received | 2015-05-08 |
| Model Number | HML400 |
| Catalog Number | HML400 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTHCARE MFG INC |
| Manufacturer Address | MIN HSIUNG, CHI YI TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-05-08 |