BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 3802823 · Received May 5, 2014

    Report

    Report Number
    1213643-2014-00129
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 11, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101928
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENTLY AVAILABLE INFO WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THIS MDR INCLUDES ALL PT, EVENT, AND DEVICE INFO DAVOL HAS RECEIVED TO DATE IF ADDITIONAL INO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S SURGEON: IT HAS BEEN ALLEGED THAT ON (B)(6) 2014 THE PT UNDERWENT A GALLBLADDER REMOVAL AND DURING THIS PROCEDURE WAS NOTED TO HAVE A VERY SMALL HERNIA AND THIS WAS REPAIRED USING A VENTRALEX ST HERNIA PATCH. POSTOPERATIVELY, THE PT BEGAN TO EXPERIENCE AN ALLERGIC TYPE RESPONSE WITH A SYSTEMIC RASH AND GENERALIZED ITCHING. THE PT HAS BEEN RATED WITH "MASSIVE" DOSES OF STEROIDS WHICH HELP WITH THE SYMPTOMS BUT THEY RETURN AS SOON AS THE MEDICATION WEARS OFF. PER SURGEON IT IS UNCLEAR IF THE VENTRALEX ST IS THE CAUSE OF THE RASH AT THIS TIME. AT THIS TIME THERE HAS BEEN NO SURGICAL INTERVENTION. HOWEVER, AS THEY MAY RESULT IN FURTHER INTERVENTION AND MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266271 VENTRALEX ST FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention