BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSN MEDICAL

    MDR report key: 19508959 · Received June 11, 2024

    Report

    Report Number
    19508959
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 16, 2024
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    ITG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RECEIVED MISLABELED PRODUCT. ITEM: 32007692, PADDING CAST STERILE 2"X4YDS, MF# 9062S MANUFACTURER RESPONSE FOR PADDING CAST STERILE 2INX4YDS 9062S, BSN MEDICAL (PER SITE REPORTER). NO RESPONSE YET - SENT PRODUCT BACK ON [DATE REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806952 BSN MEDICAL BANDAGE, CAST ITG BSN MEDICAL, INC. 315094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown