BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA-GUARD STANDARD SUCTION SET

    MDR report key: 14117780 · Received April 14, 2022

    Report

    Report Number
    MW5109015
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 1, 2022
    Report Date
    April 13, 2022
    Manufacturer
    SURGIMARK INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING OPEN HEART SURGERY CLEAR SLEEVE OF DEVICE WAS RETAINED AND PATIENT REQUIRED RETURNED TO OPERATING ROOM FOR REMOVAL FROM CHEST CAVITY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974432 VIA-GUARD STANDARD SUCTION SET CATHETER AND TIP, SUCTION JOL SURGIMARK INC. REF SMK 100

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization