FDA Adverse Event
Death
Summary report: N
NLA HYDRAULIC LIFT W/ADJ BASE-PLUS 9153633522
MDR report key: 4784872
·
Received May 20, 2015
Report
- Report Number
- 1525712-2015-03088
- Event Type
- Death
- Date Received
- May 20, 2015
- Report Date
- May 15, 2015
- Manufacturer
- UNKNOWN
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(6) 2015 - SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
PER ADMINISTRATIVE ASSISTANT FOR INVACARE'S LEGAL DEPARTMENT, THE END USER WAS BEING TRANSFERRED BY THE PATIENT LIFT AND SUFFERED SEVERE PERMANENT INJURIES AND SUBSEQUENT DEATH. THE CAREGIVERS WERE TRANSFERRING THE END USER IN A CARELESS AND NEGLIGENT MANNER CAUSING THE END USER INJURIES AND DEATH PER LEGAL NOTIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329249 | NLA HYDRAULIC LIFT W/ADJ BASE-PLUS 9153633522 | LIFT, PATIENT, NON-AC-POWERED | FSA | UNKNOWN | SELFCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |