BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUBBLE GUPPIES

    MDR report key: 9176679 · Received October 10, 2019

    Report

    Report Number
    1038758-2019-00046
    Event Type
    Injury
    Date Received
    October 10, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, PER THE INFO RECEIVED ON 09/12/2019 MEDICAL TREATMENT WOULD BE SOUGHT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. AS OF 10/09/2019 RETAINED SAMPLES OF THE SAME LOT AND UNUSED RETURNED PRODUCT SAMPLES WERE SUBMITTED TO THE LAB FOR TESTING WITH NO DEFECTS NOTED. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS.

    Description of Event or Problem · 1

    ON THE INITIAL REPORT ON 08/12/2019 CONSUMER REPORTED APPLIED THE BANDAGES TO HIS TWO SONS. HE REPORTED THAT AFTER WEARING THE PRODUCT FOR A DAY THE BANDAGES BOTH KIDS EXPERIENCED ABRASION UPON REMOVAL. THE WOUND LEFT ON THE BOYS BECAME INFECTED. REPORTER STATED BANDAGE LEFT A MARK ON THE FACE OF HIS 6 YEAR OLD SON. REFER TO THE OTHER PATIENT REPORT: 1038758-2019-00047. ON 09/12/2019 WE RECEIVED EMAIL COMMUNICATION FROM CONSUMER STATING THAT MEDICAL ATTENTION WOULD BE SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970768 BUBBLE GUPPIES WATERPROOF ANTIBACTERIAL BANDAGES KGX ASO LLC UPC#017276234855 00101157

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other