BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENTSTYLE INFANT GOWN

    MDR report key: 11581022 · Received March 29, 2021

    Report

    Report Number
    11581022
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 22, 2021
    Report Date
    March 22, 2021
    Manufacturer
    PATIENTSTYLE MEDICAL LLC
    Product Code
    FME
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    METAL SNAPS FREQUENTLY BREAK OFF/FALL OFF, EXPOSING SHARP EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479347 PATIENTSTYLE INFANT GOWN GOWN, EXAMINATION FME PATIENTSTYLE MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1