MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-03-05 for HOYER PATIENT LIFT manufactured by Apex Health Care Mfg. Inc..
[5470907]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010605276-2015-00001 |
| MDR Report Key | 4592072 |
| Report Source | 08 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-03-04 |
| Date of Event | 2014-11-28 |
| Date Mfgr Received | 2015-02-06 |
| Date Added to Maude | 2015-03-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer G1 | APEX HEALTH CARE MFG. INC. |
| Manufacturer Street | NO. 6 INDUSTRIAL 2ND ROAD TOU CHIAO INDUSTRIAL PARK, |
| Manufacturer City | MIN HSIUNG, SHIANG CHIAYI DISTRICT |
| Manufacturer Country | TW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER PATIENT LIFT |
| Generic Name | ELECTRIC PATIENT LIFT |
| Product Code | FNG |
| Date Received | 2015-03-05 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTH CARE MFG. INC. |
| Manufacturer Address | NO. 6 INDUSTRIAL 2ND ROAD TOU CHIAO INDUSTRIAL PARK, MIN HSIUNG, SHIANG CHIAYI DISTRICT TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-05 |