BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITIGEAR CHEMO GOWN WITH BLOXTECH FABRIC

    MDR report key: 10104864 · Received May 29, 2020

    Report

    Report Number
    MW5094754
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 22, 2020
    Report Date
    May 27, 2020
    Manufacturer
    CONTEC, INC.
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IV ROOM PHARMACY TECHNICIAN DISCOVERED AN INSECT INTERWOVEN INTO THE FABRIC OF STERILE GOWN. WE SEQUESTERED ALL STERILE GOWNS IN THIS LOT AND WILL BE SENDING BACK TO THE COMPANY. WE REPORTED THIS ISSUE TO THE DISTRIBUTOR ((B)(4)) AND MANUFACTURER (CONTEC). FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563670 CRITIGEAR CHEMO GOWN WITH BLOXTECH FABRIC NON-SURGICAL ISOLATION GOWN OEA CONTEC, INC. HCGA0800-2XL/3XL 7C7357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other