FDA Adverse Event
Death
Summary report: N
SARA STEDY
MDR report key: 10618980
·
Received October 2, 2020
Report
- Report Number
- 1419652-2020-00051
- Event Type
- Death
- Date Received
- October 2, 2020
- Report Date
- October 2, 2020
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, THAT PATIENT WAS USING SARA STEADY, AND FELL OUT. AS A CONSEQUENCE OF THE EVENT SUSTAINED BROKEN HIP. CUSTOMER PROVIDED INFORMATION THAT PATIENT PASSED AWAY. NO OTHER INFORMATION WAS PROVIDED. THERE ARE NO FURTHER DETAILS AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1083579 | SARA STEDY | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJOHUNTLEIGH MAGOG INC. | NTB2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |