BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO MESH

    MDR report key: 4102608 · Received September 11, 2014

    Report

    Report Number
    1213643-2014-00321
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    August 18, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100229
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED WAS LIMITED, ADDITIONAL INFO HAS BEEN REQUESTED. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO SAMPLE HAS BEEN RETURNED FOR EVALUATION. BASED ON THE INFO PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS ALLEGED. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT: IT IS ALLEGED THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO MESH PATCH DURING A REPAIR PROCEDURE IN (B)(6) 2011. REPORTEDLY, THE DAY AFTER SURGERY, THE PATIENT STOOD UP WHILE IN THE HOSPITAL, HEARD A POP AND WAS IN TREMENDOUS PAIN. THE PATIENT REPORTS THAT SHE EXPERIENCED ( UNDEFINED) COMPLICATIONS AFTER THE IMPLANT PROCEDURE. THE PATIENT ALLEGES THAT SHE UNDERWENT AN EXPLANT PROCEDURE AND THAT THE MESH WAS FOUND TO BE HARD, ROLLED UP AND STUCK TO THE BOWELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563104 VENTRIO MESH FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUI0013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention