BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 11874024 · Received May 25, 2021

    Report

    Report Number
    1000599868-2021-00008
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 28, 2021
    Report Date
    April 29, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. UDI #:(B)(4). UPC #3381370044444, EXPIRATION DATE: NA, LOT #: 190213. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON FEBRUARY 14, 2019. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A MALE CONSUMER OF UNKNOWN AGE REPORTED AN EVENT WITH BAB FLEXIBLE FABRIC 1IN. THE CONSUMER STATED HE HAD A PIMPLE AND USED THE PRODUCT TO COVER IT UP ON (B)(6) 2021. CONSUMER REPORTED THE AREA WAS REDDISH AND SENSITIVE TO THE TOUCH ONE DAY AFTER APPLICATION, (B)(6) 2021. THE CONSUMER SOUGHT MEDICAL CONSULTATION AND WAS TOLD TO APPLY AN UNKNOWN CREAM TO THE SITE. CONSUMER IS STILL EXPERIENCING SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777369 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC. 381370044444 190213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention