BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC EXTRA LARGE

    MDR report key: 14723732 · Received June 16, 2022

    Report

    Report Number
    2214133-2022-00027
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    November 5, 2021
    Report Date
    May 26, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    KGX
    UDI-DI
    381370056850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. BRAND NAME, COMMON DEVICE NAME, MANUFACTURER NAME, CITY, AND STATE, LOT #: THIS REPORT IS FOR BAB FLEXIBLE FABRIC EXTRA LARGE USA 381370056850, LOT NUMBER- 210516. UDI #: (B)(4). UPC #:381370056850, EXPIRATION DATE: NA. LOT #: 210516. CONCOMITANT MEDICAL PRODUCTS: 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 MAY 16, 2021. (B)(4). 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 · 0

    A FEMALE CONSUMER REPORTED AN EVENT WITH BAND AID BANDAGE FLEXIBLE FABRIC EXTRA LARGE. IT WAS REPORTED THAT A CONSUMER USED A BAND-AID ON SEPARATE WOUND ON THE LEFT BREAST TO COVER A SCRATCH FROM SCRATCHING A MOLE. THE CONSUMER REPORTED THAT HER SKIN WAS PEELED/RIPPED OFF WITH THE ADHESIVE ON THE BAND-AID WHEN SHE TOOK IT OFF. THE EVENT OCCURRED ON (B)(6) 2021 AND WAS VERY PAINFUL. IT WAS ALSO REPORTED THAT THE WOUND WAS OOZING CLEAR LIQUID. DUE TO PAIN, FOR 3 DAYS AND IT WAS NOT GETTING BETTER, SHE SOUGHT FOR PROPER MEDICAL HELP. ON (B)(6) 2021, IN URGENT/OUTPATIENT CARE, AN OPEN WOUND ON THE LEFT BREAST, INITIAL ENCOUNTER, WAS OBSERVED AND ADDRESSED. CEPHALEXIN/KEFLEX WAS PRESCRIBED WITH CHANGE DRESSING TWICE DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194433 BAB FLEXIBLE FABRIC EXTRA LARGE TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC. 381370056850 210516 381370056850

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention