FDA Adverse Event
Death
Summary report: N
V4
MDR report key: 2950563
·
Received February 5, 2013
Report
- Report Number
- 9681684-2013-00013
- Event Type
- Death
- Date Received
- February 5, 2013
- Date of Event
- December 23, 2012
- Report Date
- January 28, 2013
- Manufacturer
- ARJOHUNTLEIGH MAGOIG INC.
- Product Code
- FNG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
THE PT WAS BEING LIFTED WITH THE ASSISTANCE OF A CEILING LIFT WHEN ONE OF THE SLING LOOPS BECAME UNATTACHED AND SHE FELL FORM THE SLING, CAUSING INJURIES. THE PT WAS VERY FRAIL, SHE HAD BROKEN BOTH LEGS AND LATER DECEASED FROM COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47825 | V4 | MANUFACTURED CEILING FIXED CASSETTES | FNG | ARJOHUNTLEIGH MAGOIG INC. | 9100201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |