BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM

    MDR report key: 15362732 · Received September 2, 2022

    Report

    Report Number
    MW5111871
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 27, 2022
    Report Date
    August 31, 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
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PT WITH 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 PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617338 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