BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED 0.7ML - 12EA

    MDR report key: 10830012 · Received November 12, 2020

    Report

    Report Number
    2210968-2020-08986
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    UDI-DI
    10705031203532
    PMA / PMN Number
    K152096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING INFORMATION HAS BEEN REQUESTED AND RECEIVED. TO DATE THE DEVICE HAS NOT BEEN RECEIVED. IF THE FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4): ICD GENERATOR CHANGE - RN/4500653, (B)(6) YEAR OLD MALE, ALLERGY TO TETRACYCLINE ADDITIONAL INFORMATION RECEIVED IN EMAIL UNDER RELATED FILE: (B)(4) (3 NEW/ADDITIONAL FILES RAISED): CAN YOU IDENTIFY THE PRODUCT CODE OF THE DEVICE? DNX12. CAN YOU IDENTIFY THE LOT NUMBER OF THE DEVICE? QEBDTD. WHAT IS THE PROCEDURE NAME AND INITIAL PROCEDURE DATE? ICD GENERATOR CHANGE WHAT DATE DID THE BLISTER/SKIN REACTION OCCUR ON? (B)(6) 2020. DO YOU HAVE ANY PICTURES OF THE REACTION? NO. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. ANTIBIOTICS PRESCRIBED AT TIME OF DISCOVERY ON (B)(6) 2020. WHAT IS THE MOST CURRENT PATIENT STATUS? ALIVE. WILL THE APPLICATORS BE RETURNED FOR EVALUATION? THE REMAINING FROM THE LOT CAN BE RETURNED. HOW WAS THE PRODUCT APPLIED? STERILELY. HOW MANY LAYERS OF THE PRODUCT WERE APPLIED? 2. WHAT PREP WAS USED PRIOR TO PRODUCT APPLICATION? CHLOROPREP PRIOR TO INCISION. IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? NO. IF THE PATIENT IS FEMALE, PLEASE ASK IF THEY WERE EXPOSED TO SIMILAR PRODUCTS, SUCH AS ARTIFICIAL NAILS? NO ARTIFICIAL NAILS PATIENT DEMOGRAPHICS: INITIALS / ID; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS). HOW MANY DERMABOND ADVANCED PRODUCTS WERE USED ON EACH PATIENT WITH A REACTION? TWO PRODUCTS WERE USED ON EACH PATIENT WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THESE PATIENTS IN PREVIOUS SURGERIES OR WOUND CLOSURES? NO. NOTE: EVENTS REPORTED ON MW# 2210968-2020-08987.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A ICD GENERATOR CHANGE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT DEVELOPED A BLISTER AND SKIN REACTION. ANTIBIOTICS PRESCRIBED AT TIME OF DISCOVERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295956 DERMABOND ADVANCED 0.7ML - 12EA ADHESIVE, TOPICAL SKIN MPN ETHICON INC. DNX12 QEBDTD 10705031203532

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention