FDA Adverse Event
Other
Summary report: N
8030916-2008-00029
MDR report key: 1150134
·
Received September 2, 2008
Report
- Report Number
- 8030916-2008-00029
- Event Type
- Other
- Date Received
- September 2, 2008
- Product Code
- FSA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
LOCAL DISTRIBUTOR RECEIVED NOTIFICATION OF POSSIBLE INCIDENT AT THIS FACILITY. PHONE CALL TO FACILITY ON 8/6/08 REP SPOKE WITH ADMIN WHO DID NOT KNOW DATE OF THIS ALLEGED INCIDENT, COULD NOT PROVIDE LIFT MODEL TYPE OR SERIAL NUMBER. USER GUIDES ARE CLEAR IN INSTRUCTION AS TO THE PROPER AND SAFE USE OF THE PRODUCT. THIS INCIDENT IS VIEWED AS USER ERROR AND NOT A PRODUCT PROBLEM. LIFT IS STILL IN USE AT THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FSA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |