BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM

    MDR report key: 8662390 · Received June 3, 2019

    Report

    Report Number
    2210968-2019-82247
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 5, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    UDI-DI
    10705031237339
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE INDICATE ANY MEDICAL OR SURGICAL INTERVENTIONS PERFORMED. HYDROCORTISONE PRESCRIBED. PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED ON THE TAPE. ONE LAYER APPLICATION. WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING USED? NO. IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? UNKNOWN. IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? UNKNOWN. WERE ANY PATCH OR SENSITIVITY TESTS PERFORMED? NO. IT WAS NOTED A QUANTITY OF 2 WAS USED ON THE PATIENT, PLEASE VERIFY THAT 2 PRODUCTS OF PRINEO 22 WERE ACTUALLY USED? YES. DO YOU HAVE THE LOT NUMBER INVOLVED ? NO. WHAT IS THE PHYSICIANS OPINION OF THE CONTRIBUTING FACTORS TO THE REACTION? SENSITIVE SKIN. WHAT IS THE MOST CURRENT PATIENT STATUS? DISCHARGED . IS THE PRODUCT OR REPRESENTATIVE SAMPLE (PRODUCT FROM THE SAME LOT NUMBER) AVAILABLE FOR EVALUATION? NO. PATIENT DEMOGRAPHICS: INITIALS / ID; AGE OR DATE OF BIRTH; BMI ; GENDER. FEMALE PATIENT. OTHERS NOT AVAILABLE. PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS). UNKNOWN. WAS PRINEO/DEMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? NO. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A RIGHT DIEP FLAP PROCEDURE ON (B)(6) 2019 AND TOPICAL SKIN ADHESIVE WAS USED. ON POST OP DAY (B)(6) 2019, THE PATIENT DEVELOPED REDNESS, ALLERGIC REACTION AROUND ADHESIVE APPLICATION SITE. THE ADHESIVE WAS REMOVED AND HYDROCORTISONE PRESCRIBED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457995 DERMABOND PRINEO 22CM SURGICAL SEALANT OMD ETHICON INC. 10705031237339

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention