BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SOFRADIM PRODUCT

    MDR report key: 883399 · Received July 18, 2007

    Report

    Report Number
    9615742-2007-00019
    Event Type
    Malfunction
    Date Received
    July 18, 2007
    Report Date
    April 12, 2007
    Manufacturer
    TREVOUX - USS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, "I HAVE A PATIENT WHO DEVELOPED AN ALLERGIC REACTION ABOUT TWO WEEKS AFTER GETTING A HERNIA REPAIR WITH PARIETEX MESH." THE PATIENT'S RASH HAS RESOLVED WITH NO FURTHER CONCERN. PROCEDURE: HERNIA. DURING A ROUTINE REVIEW OF OUR COMPLAINTS THIS FTR WAS RE-EVALUATED. BECAUSE THE INFORMATION IN THE EVENT DESCRIPTION IS INSUFFICIENT TO SUPPORT A CONCLUSION THAT A DEVICE RELATED MALFUNCTION DID NOT OCCUR THE COMPLAINT WILL BE REPORTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SOFRADIM PRODUCT SURGICAL MESH FTL TREVOUX - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR