BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 3940889 · Received July 9, 2014

    Report

    Report Number
    1213643-2014-00213
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 15, 2013
    Report Date
    June 17, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION THAT HAS BEEN PROVIDED IS LIMITED AND DOES NOT INCLUDE PRODUCT IDENTIFIERS. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING COULD NOT BE CONDUCTED. ADDITIONALLY, RECURRENCE IS A KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. ADDITIONAL INFORMATION HAS BEEN REQUESTED. BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, A BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING HAS BEEN ALLEGED BY THE PATIENT: ON (B)(6) 2009 - THE PATIENT WAS IMPLANTED WITH A BARD VENTRALEX PATCH FOR PERI-UMBILICAL HERNIA REPAIR. POST OPERATIVELY THE PATIENT DID WELL; THERE WERE NO COMPLICATIONS. ON (B)(6) 2009 - THE PATIENT NOTICED DISTENSION AROUND HER UMBILICUS AND EXPERIENCED CONSTIPATION. SHE DID NOT SEEK MEDICAL TREATMENT. ON (B)(6) 2013 - THE PATIENT UNDERWENT HERNIA REPAIR SURGERY FOR A RECURRENCE OF HER HERNIA AND WAS IMPLANTED WITH A NON-BARD DEVICE. IT IS UNKNOWN TO THE PATIENT IF THE BARD VENTRALEX PATCH WAS EXPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401521 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention