MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-22 for HOYER PRESENCE LIFT HOY-PRESENCEWSC manufactured by Apex Healthcare Mfg Inc.
[5826719]
It was reported to the manufacturer by the end user, per the end user the pt slipped out of the lift. The pt was injured and taken to the hosp for medical attention. The resident sustained a bump on the head and was returned to the facility. The facility administrator refused to answer any add'l questions due to hipaa.
Patient Sequence No: 1, Text Type: D, B5
[13328120]
Joerns sending the report to the mfr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009402404-2015-00010 |
| MDR Report Key | 4734282 |
| Report Source | 06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-03-30 |
| Date Facility Aware | 2015-03-30 |
| Report Date | 2015-04-21 |
| Date Reported to FDA | 2015-04-21 |
| Date Reported to Mfgr | 2015-04-21 |
| Date Mfgr Received | 2015-03-31 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2015-04-29 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| 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 PRESENCE LIFT |
| Generic Name | ELECTRIC PT LIFT |
| Product Code | FNG |
| Date Received | 2015-04-22 |
| Model Number | HOY-PRESENCEWSC |
| Catalog Number | HOY-PRESENCEWSC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 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 | 2015-04-22 |