FDA Adverse Event
Malfunction
Summary report: N
ENCORE
MDR report key: 3771223
·
Received January 14, 2014
Report
- Report Number
- 9611530-2014-00004
- Event Type
- Malfunction
- Date Received
- January 14, 2014
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP Z.O.O.
- Product Code
- FSA
- 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 AB LTD. AS OF (B)(4) 2010, THE 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 HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WILL BE SUBMITTED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON 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 |
|---|---|---|---|---|---|---|---|
| 37803 | ENCORE | FSA | ARJOHUNTLEIGH POLSKA SP Z.O.O. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |