BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO ST

    MDR report key: 23887427 · Received December 24, 2025

    Report

    Report Number
    1213643-2025-01264
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 4, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031540
    PMA / PMN Number
    K101920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. NOTE, THE DATE OF EVENT (02-DEC-2025) AND MANUFACTURING DATE (15-SEP-2022) ARE CONSIDERED TO BE THE BEST ESTIMATE. THIS EMDR REPRESENTS THE BD VENTRIO ST (LOT - HUGW1573). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE OTHER TWO BD VENTRIO ST MESHES (LOT - HUGV0211 AND LOT - HUEW1693). 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

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF THREE BARD/DAVOL VENTRIO ST MESH (CAT# 5950020, LOT# HUEW1693) ON (B)(6) 2021 AND (CAT# 5950020, LOT# HUGV0211) ON (B)(6) 2023 AND (CAT# 5950050, LOT# HUGW1573) ON (B)(6) 2024. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL VENTRIO ST MESHES. 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
    2531654 VENTRIO ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUGW1573 00801741031540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability