BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ADV AB W/P ADH PAD 3X4 6CT

    MDR report key: 12474161 · Received September 15, 2021

    Report

    Report Number
    1417592-2021-00167
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 24, 2021
    Report Date
    September 15, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE END-USER EXPERIENCED A SKIN REACTION. APPROXIMATELY 6-8 HOURS AFTER APPLYING THE BANDAGE TO THE CENTER OF HIS CHEST, THE END-USER EXPERIENCED PAIN TO HIS ARM AND HIS COLLAR BONE. REPORTEDLY, WHEN THE END-USER REMOVED THE BANDAGE, SOME OF THE SKIN IN CONTACT WITH THE BANDAGE ADHESIVE CAME OFF AND HE NOTED A "WELT" AT THE APPLICATION SITE. THE END-USER WAS EVALUATED BY HIS PHYSICIAN WHO INFORMED HIM THAT HE HAD EXPERIENCED A SKIN REACTION TO THE BANDAGE ADHESIVE. THE END-USER WAS PROVIDED WITH A PRESCRIPTION FOR TRIAMCINOLONE ACETONIDE CREAM USP, 0.1% AND REPORTED THAT AFTER USING THE CREAM, THE SWELLING SUBSIDED AND THE APPLICATION SITE "SCABBED OVER." NO FURTHER MEDICAL TREATMENT OR FOLLOW-UP CARE WAS REPORTED. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE LOT NUMBER FOR THE PRODUCT USED WAS NOT PROVIDED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END-USER EXPERIENCED A SKIN REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371499 RX ADV AB W/P ADH PAD 3X4 6CT FRO MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention