BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM

    MDR report key: 7731045 · Received July 30, 2018

    Report

    Report Number
    7731045
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    June 21, 2018
    Report Date
    June 30, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OQL
    UDI-DI
    00801741031755
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MESH DEVICE BROKE OFF IN ABDOMEN INSTEAD OF COMING OUT IN ONE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574152 VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM MESH, SURGICAL, DEPLOYMENT BALLOON OQL DAVOL INC., SUB. C.R. BARD, INC. 5955680 HUBT1674 00801741031755

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA