BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID KPP REGULAR 10 2013

    MDR report key: 6596451 · Received May 29, 2017

    Report

    Report Number
    2214133 -2017-00004
    Event Type
    Injury
    Date Received
    May 29, 2017
    Date of Event
    May 7, 2017
    Report Date
    May 8, 2017
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON 29-MAY2017 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (BAB ADV HEALING BLISTER FINGER TOE 8S). THIS CLOSES OUT THE REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2017 FROM PEDIATRICIAN REPORTING ON (B)(6) OLD MALE CONSUMER FROM (B)(6). THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE MOTHER STARTED USING BAND AID KPP REGULAR 10 2013, BY MISTAKE, ON (B)(6) OLD SON, (DEVICE USE FOR UNAPPROVED AGE GROUP), FOR A WOUND ON FACE (ROUTE: CUTANEOUS, LOT NUMBER, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). ON (B)(6) 2017 IN THE EVENING, THE MOTHER USED THE DEVICE ON THE FACE OF THE SON FOR THE SECOND TIME AND HE DEVELOPED HIVES (URTICARIA) ON FACE. THE REPORTER MENTIONED THAT IT WAS NOT LIKE A SYMPTOM OF ANAPHYLAXIS. ON (B)(6) 2017, THE PEDIATRICIAN WAS CONSULTED WHO MENTIONED THAT IT WAS NOT CLEARLY DIAGNOSED AS ATOPIC ECZEMA BUT THE CONSUMER HAD SENSITIVE AND DELICATE SKIN. THE MOTHER TOOK THE SON TO THE HOSPITAL WHERE HE WAS INFUSED WITH UNSPECIFIED DRUG TO TREAT THE EVENT. THE REPORTER MENTIONED THAT THE CAUSE WAS NOT SPECIFIED AS KPP. IT WAS ALSO REPORTED THAT SON DID NOT EXPERIENCE ANY ADVERSE EVENT AFTER USAGE OF THE DEVICE FOR THE FIRST TIME. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. AFTER AN UNSPECIFIED DURATION IN (B)(6) -2017, THE EVENT HIVES RESOLVED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378200 BAND AID KPP REGULAR 10 2013 ADHESIVE BANDAGE KGX SKILLMAN CONTRACT NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention