BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH WITH ECHO PS

    MDR report key: 14043766 · Received April 6, 2022

    Report

    Report Number
    MW5108819
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    February 18, 2022
    Report Date
    April 4, 2022
    Manufacturer
    BARD DAVOL, INC. / DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PROCEDURE, DEPLOYMENT SYSTEM MALFUNCTIONED AND WAS NOT ABLE TO BE INSUFFLATED PER SURGEON. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013063 VENTRALIGHT ST MESH WITH ECHO PS MESH, SURGICAL, DEPLOYMENT BALLOON OQL BARD DAVOL, INC. / DAVOL INC., SUB. C.R. BARD, INC. 5955450 HUFX0496

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female