FDA Adverse Event
Malfunction
Summary report: N
ALPHA RELIEF
MDR report key: 3606759
·
Received January 22, 2014
Report
- Report Number
- 1000381138-2014-00002
- Event Type
- Malfunction
- Date Received
- January 22, 2014
- Manufacturer
- ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
- Product Code
- FNM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED (B)(4). AS OF 2011, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, A BRANCH OF ARJO LIMITED MED (B)(4). ADD'L INFO WILL BE PROVIDED UPON 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 |
|---|---|---|---|---|---|---|---|
| 52948 | ALPHA RELIEF | FNM | ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |