BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BANDAGE SELF ADHERENT 2X5YD LF NS 36EA/B

    MDR report key: 7940544 · Received October 5, 2018

    Report

    Report Number
    1423537-2018-00241
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 5, 2018
    Manufacturer
    3H MEDICAL PRODUCTS CO., LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER¿S INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD HAVE LED TO THE REPORTED INCIDENT. NO SAMPLE WAS RETURNED FOR THE INVESTIGATION. PHOTOS OF THE PATIENT WITH ALLERGIC REACTION WERE PROVIDED. THE SUPPLIER REVIEWED THEIR BIO COMPATIBILITY TEST REPORT, THE TEST RESULT SHOWED THAT THE PRODUCT DOES NOT INDUCE IRRITATION TO SKIN. A SIMILAR COMPLAINT REVIEW WAS DONE FOR THE PAST 12 MONTHS AND THERE WERE NO ALLERGIC REACTION COMPLAINTS FOR THIS PRODUCT. FROM THE INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THERE IS NO ADDITIONAL ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A BLOOD DRAWN AT (B)(6) CLINIC, THEY USED A SELF-ADHERENT BANDAGE TO HOLD THE COTTON BALL IN PLACE. WITHIN 15 MINUTES, PATIENT HAD AN ALLERGIC REACTION-REDNESS/RASH ON FACE. PATIENT STATES THEY HAVE AN AUTO-IMMUNE DISEASE AND THEY WERE ALREADY ON AN ANTIHISTAMINE WHEN REACTION OCCURRED. UPON REMOVING THE SELF ADHERENT BANDAGE THE REACTION BEGAN TO SUBSIDE, NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781535 BANDAGE SELF ADHERENT 2X5YD LF NS 36EA/B TAPE AND BANDAGE, ADHESIVE KGX 3H MEDICAL PRODUCTS CO., LTD. CAH45LF LF180115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other