BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS

    MDR report key: 5768900 · Received July 5, 2016

    Report

    Report Number
    1038758-2016-00081
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 07/05/2016 ASO HAS NOT RECEIVED FURTHER INFORMATION FROM THE CONSUMER. ASO HAS NOTIFIED THE MANUFACTURER ABOUT THE EVENT. ASO WILL FOLLOW-UP ON THIS REPORT AS SOON AS WE RECEIVE FURTHER INFORMATION FROM THE CONSUMER. AS OF 09/09/2016 BASED OF BATCH RECORD REVIEW AND TESTING, NO ISSUES WERE OBSERVED WITH THESE PRODUCTS.

    Additional Manufacturer Narrative · 1

    AS OF 07/05/2016 ASO HAS NOT RECEIVED FURTHER INFORMATION FROM THE CONSUMER. ASO HAS NOTIFIED THE MANUFACTURER ABOUT THE EVENT. ASO WILL FOLLOW-UP ON THIS REPORT AS SOON AS WE RECEIVE FURTHER INFORMATION FROM THE CONSUMER. NO SAMPLES OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT HE EXPERIENCED PAIN AFTER USING THE PREMIUM HEALING BANDAGES (HYDROCOLLOIDS). HE BELIEVED THAT THE BANDAGES WERE BLOCKING HIS SUNSCREEN AND WHEN THE SUN HITS THEM IT GETS MAGNIFIED. HE HAD BLISTERS IN THE SHAPE OF THE BANDAGES AND LOOKED LIKE THIRD DEGREE BURNS.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT HE EXPERIENCED PAIN AFTER USING THE PREMIUM HEALING BANDAGES (HYDROCOLLOIDS). HE BELIEVED THAT THE BANDAGES WERE BLOCKING HIS SUNSCREEN AND WHEN THE SUN HITS THEM IT GETS MAGNIFIED. HE HAD BLISTERS IN THE SHAPE OF THE BANDAGES AND LOOKED LIKE THIRD DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422774 WALGREENS ADVANCE HEALING HYDROCOLLOID BANDAGE NAD EUROMED, INC. UPC311917143378 B1511091

    Patients

    Seq Age Sex Outcome Treatment
    1