BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 8711897 · Received June 19, 2019

    Report

    Report Number
    1038758-2019-00016
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    May 20, 2019
    Report Date
    May 21, 2019
    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 06/03/2019 ASO COULD NOT CONFIRM THE LOT NUMBER FOR ADDITIONAL INVESTIGATION. SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED. REFER TO B.6 FOR FURTHER DETAILS. COMPLAINT DATABASE WAS REVIEWED; THERE WAS NO NEGATIVE TREND IDENTIFIED FOR THE ASSOCIATED PRODUCT.

    Description of Event or Problem · 1

    CONSUMER STATED THAT PRODUCT WAS STUCK COMPLETELY TO WOUND. CONSUMER REPORTED THAT SHE WENT TO THE URGENT CARE FOR ASSISTANCE AND IT WAS EXCRUCIATINGLY PAINFUL. SHE RECEIVED PRESCRIPTION ANTIBACTERIAL CREAM AND NONSTICK GAUZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506140 CVS HEALTH HYDROCOLLOID BLISTER CARE CUSHIONS NAD EUROMED, INC. UPC#050428253212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other