FDA Adverse Event
Malfunction
Summary report: N
MAXI LITE
MDR report key: 3110551
·
Received April 11, 2013
Report
- Report Number
- 9681684-2013-00034
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC
- Product Code
- FSA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH INC., ON BEHALF OF THE MANUFACTURER (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154792 | MAXI LITE | MANUFACTURED FLOOR PASSIVE LIFT | FSA | ARJOHUNTLEIGH MAGOG INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |