BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM

    MDR report key: 15362892 · Received September 2, 2022

    Report

    Report Number
    MW5111877
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Report Date
    September 1, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH AN INCARCERATED VENTRAL HERNIA UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH ON (B)(6) 2022. THE PRODUCT DEVICE USED WAS BARD VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM (REF. 5955680). DURING THE PROCEDURE, THE YELLOW ANCHOR PIECE (THAT IS ATTACHED TO THE BLUE RETRIEVAL LOOP) BROKE OFF BETWEEN THE MESH AND THE ABDOMINAL WALL. THE YELLOW ANCHOR PIECE WAS NOT RETRIEVED AND REMAINS ON THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617346 VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM MESH, SURGICAL, POLYMERIC FTL DAVOL INC., SUB. C.R. BARD, INC. 5955680 HUGQ1291

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female