BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED PATPAT PACIFIER

    MDR report key: 8413956 · Received March 11, 2019

    Report

    Report Number
    MW5084819
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    December 15, 2018
    Report Date
    February 12, 2019
    Manufacturer
    RYAN AND ROSE, LLC
    Product Code
    MEF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY (B)(6) BIT THROUGH THE PATPAT PACIFIER. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204062 RED PATPAT PACIFIER RING, TEETHING, NON-FLUID FILLED MEF RYAN AND ROSE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO