BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVSPHARMACY

    MDR report key: 7954248 · Received October 10, 2018

    Report

    Report Number
    1038758-2018-00028
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    September 3, 2018
    Report Date
    September 10, 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

    ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AS WELL AS MANUFACTURER'S TESTS WITH NO ISSUES REPORTED. MANUFACTURER STATED THAT THERE IS NO EVIDENCE OF A TREND ASSOCIATED WITH THE BANDAGES THAT WOULD INDICATE AN INCREASED RISK TO USER SAFETY. ASO COMPLAINT DATABASE WAS REVIEWED; THERE WAS NO (B)(6) TREND IDENTIFIED FOR THE ASSOCIATED PRODUCT. REFER THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 1

    THE INITIAL REPORT ON (B)(6) 2018 CONSUMER INFORMED THAT PRODUCT WAS USED TO COVER BURN. CUSTOMER STATED THAT SHE FEELS THAT BURN MAY HAVE GOT WORSE AFTER USING THE PRODUCT. CONSUMER STATED THAT SHE HAS REMOVED BANDAGE AND PRODUCT RIPPED HER SKIN AROUND BURN AREA. COSTUMER REQUESTED COMPOSITION OF BANDAGE. THE COMPLETED CUSTOMER INFORMATION REQUEST (CIR) WAS RECEIVED ON 09/24/2018. CONSUMER STATED THAT SHE REMOVED BANDAGE WITHIN THE FIRST DAY AS THE BANDAGE DID NOT SEAL PROPERLY. CUSTOMER REQUIRED MEDICAL TREATMENT AND THE SYMPTOMS DID NOT CORRECT AFTER SHE STOPPED USING THE PRODUCT. HER DOCTOR PRESCRIBED A BURN OINTMENT AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794674 CVSPHARMACY ADVANCED HEALING PREMIUM BANDAGES NAD EUROMED, INC. UPC#050428171240 00007247

    Patients

    Seq Age Sex Outcome Treatment
    1 Other