BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 9612797 · Received January 21, 2020

    Report

    Report Number
    1000599868-2020-00002
    Event Type
    Injury
    Date Received
    January 21, 2020
    Report Date
    December 27, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370044444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE BAB FLEXIBLE FABRIC 1IN 100S USA (B)(4). UPC #: (B)(4), LOT #: 190227, EXP DATE: NA, UDI #: (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION 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 10-MAR-2019. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A MALE CONSUMER REPORTED AN EVENT WITH BAND AID BANDAGE FLEXIBLE FABRIC 1IN. THE CONSUMER USED THE PRODUCT TO COVER A WOUND. THE CONSUMER STATED THAT THE PRODUCT WAS VERY HARD TO REMOVE IT, BUT HE WAS ABLE TO REMOVE IT USING HOT WATER. WHEN HE DID REMOVE IT, IT PEELED OFF HIS SKIN. CONSUMER VISITED URGENT CARE FOR TREATMENT. THE CONSUMER IS NO LONGER EXPERIENCING ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76202 BAB FLEXIBLE FABRIC BANDAGES ADHESIVE BANDAGES KGX JOHNSON & JOHNSON CONSUMER INC 381370044444 190227 381370044444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention