FDA Adverse Event
Injury
Summary report: N
MAXI MOVE
MDR report key: 3952408
·
Received July 2, 2014
Report
- Report Number
- 9611530-2014-00044
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 17, 2014
- Manufacturer
- ARJO MED AB LTD.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED LTD. AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
REFERENCE IMPORTER # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385549 | MAXI MOVE | FSA | ARJO MED AB LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |