BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2860124 · Received November 29, 2012

    Report

    Report Number
    1213643-2012-00830
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 12, 2012
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MD ALLEGES THAT THE PATIENT HAD A "SEVERE ALLERGIC REACTION" FOLLOWING IMPLANT. CURRENTLY, AN ALLERGY TEST HAS NOT BEEN CONDUCTED AND IT APPEARS THE MESH REMAINS IMPLANTED. ADDITIONALLY, PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED THEREFORE MANUFACTURING REVIEW IS NOT POSSIBLE. WITH THE LIMITED INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PATIENT'S MD: ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A VENTRALEX MESH DURING REPAIR OF AN UMBILICAL HERNIA. TWO WEEKS LATER THE PATIENT BEGAN TO EXPERIENCE A "SEVERE ALLERGIC REACTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention