BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 8241826 · Received January 11, 2019

    Report

    Report Number
    1038758-2018-00031
    Event Type
    Injury
    Date Received
    January 11, 2019
    Date of Event
    November 20, 2018
    Report Date
    November 21, 2018
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 01/10/"2018" THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT "INDICATED" THAT AN MDR WOULD BE REQUIRED. HOWEVER, THE CONSUMER STATED THAT MEDICAL ATTENTION WAS "SOUGH" ON (B)(6) 2018. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AND NOTIFIED THE MANUFACTURER ABOUT THE EVENT.

    Description of Event or Problem · 1

    THE INITIAL REPORT ON 11/21/2018: CONSUMER INFORMED THAT SHE HAD AN ALLERGIC REACTION AFTER REMOVING THE BANDAGE. CONSUMER STATED THAT SHE ORIGINALLY BURNED HER HAND AND APPLIED THE BANDAGE. THE COMPLETED CUSTOMER INFORMATION REQUEST (CIR) WAS RECEIVED ON 12/12/2018. CONSUMER INFORMED THAT THE SYMPTOMS DID NOT CORRECT AFTER SHE STOPPED USING THE PRODUCT. SHE REQUIRED TREATMENT WITH STEROID CREAMS AND BACITRACIN IN ORDER TO CORRECT THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33336 CVS HEALTH ADVANCED HEALING HYDROCOLLOID BANDAGES NAD EUROMED, INC. UPC#050428276037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other