BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6999641 · Received November 3, 2017

    Report

    Report Number
    1038758-2017-00039
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    September 25, 2017
    Report Date
    September 25, 2017
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2017 THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, THE CONSUMER STATED ON (B)(6) 2017 THAT SHE REQUIRED TREATMENT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AS WELL AS REVIEWING THE MANUFACTURER'S SUMMARY WITH NO ISSUES DETECTED.

    Description of Event or Problem · 1

    THE INITIAL REPORT ON (B)(6) 2017, CUSTOMER STATED THAT THE PRODUCT CAUSED HER AN IRRITATION IN THE SHAPE OF THE PRODUCT. HOWEVER, ON (B)(6) 2017 THE CONSUMER SENT THE COMPLETED CIR INDICATING THAT SHE REQUIRED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780356 WELL AT WALGREENS ADVANCED HEALING LARGE PREMIUM BANDAGES NAD EUROMED, INC. UPC#311917143378 00051452

    Patients

    Seq Age Sex Outcome Treatment
    1