BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 18464082 · Received January 8, 2024

    Report

    Report Number
    1213643-2023-095445
    Event Type
    Injury
    Date Received
    January 8, 2024
    Report Date
    January 8, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031663
    PMA / PMN Number
    K101851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT"; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER LEGAL COURT FILE: ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH THE BARD/DAVOL VENTRALIGHT ST MESH COLLECTIVELY KNOWN AS "MESH PRODUCT". ON (B)(6) 2011, PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA AND IMPLANTED WITH A 17.8CM X 22.9CM SIZED PIECE OF A VENTRALIGHT ST MESH (CAT #5954790, LOT #HUUJ0736). ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907771 VENTRALIGHT ST MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUJ0736 00801741031663

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability