FDA Adverse Event
Malfunction
Summary report: N
TEMPO
MDR report key: 3471249
·
Received November 1, 2013
Report
- Report Number
- 9681684-2013-00084
- Event Type
- Malfunction
- Date Received
- November 1, 2013
- Manufacturer
- ARJO MED AB LTD
- Product Code
- FSA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MFG AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED AB LTD. AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562980 | TEMPO | FSA | ARJO MED AB LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |