BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS

    MDR report key: 16860744 · Received May 3, 2023

    Report

    Report Number
    1038758-2023-00009
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    April 13, 2023
    Report Date
    May 3, 2023
    Manufacturer
    QIDONG FARJOY MEDICAL MATERIAL CO LTD
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT CONFIRM THAT AN MDR WOULD BE REQUIRED. HOWEVER, PER THE INFO RECEIVED ON 04/13/2023 CONSUMER STATED MEDICAL TREATMENT WAS SOUGHT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. AS OF 04/24/2023 UNUSED RETURNED PRODUCT WERE SUBMITTED TO THE LAB FOR TESTING WITH NO DEFECTS NOTED. ALSO MANUFACTURER EVALUATED RETAINED SAMPLES OF THE SAME LOT WITH NO DEFECTS NOTED. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED ON 03/15/2023 THAT PRODUCT CAUSED AN ADVERSE REACTION. THE CONSUMER INFORMED US THAT SHE WANTS TO FILE A CLAIM FOR MEDICAL SERVICES AND SUPPLIES. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON 04/13/2023, SHE CONFIRMED SHE SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED GABAPENTIN 300MG AND OVER-THE-COUNTER MEDICATION VITAMIN E AND CALAMINE. SHE ADDED THAT THE SYMPTOMS WERE CORRECT AFTER SHE STOPPED USING THE PRODUCT, BUT SHE HAS A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714167 WALGREENS CLEAR TAPE KGX QIDONG FARJOY MEDICAL MATERIAL CO LTD UPC#311917205489 3385-20210802

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other