BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODESIGN SURGISIS MESH

    MDR report key: 13618903 · Received February 25, 2022

    Report

    Report Number
    MW5107744
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 23, 2022
    Report Date
    February 23, 2022
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED THE OFFICE TO REPORT SHE HAD SEEN A PLASTIC SURGEON AND WAS TOLD THE MESH INSERTED (B)(6) 2019 WAS "BALLED UP ON THE LEFT SIDE". FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298093 BIODESIGN SURGISIS MESH MESH, SURGICAL FTM COOK BIOTECH, INC. LB1127698

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other