BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN UNSCENTED CPAP MASK WIPES

    MDR report key: 17286814 · Received July 7, 2023

    Report

    Report Number
    MW5119212
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED A SEALED PRODUCT TWICE THAT WAS DISTENDED. REPORTED ISSUE TO THE COMPANY THE FIRST TIME A MONTH AGO AND THEY SENT A REPLACEMENT THAT WAS ALSO DISTENDED. NO TESTING DONE BY CONSUMER. REFERENCE REPORT: MW5119211.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687562 SOCLEAN UNSCENTED CPAP MASK WIPES DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other