BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE

    MDR report key: 13625008 · Received February 28, 2022

    Report

    Report Number
    2210968-2022-01378
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    April 1, 2021
    Report Date
    February 28, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    UDI-DI
    10705031230996
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION: DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO. IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? TOPICAL STEROIDS AND ANTIHISTAMINES WAS PRESCRIBED TO PATIENT FOR THE ALLERGIC REACTION. PATIENT STATUS/ OUTCOME / CONSEQUENCES? YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PATIENT EXPERIENCED ALLERGIC CONTACT DERMATITIS FROM SECOND USE OF DERMABOND PRINEO, THE SKIN SURROUNDING THE WOUND WHERE PRINEO WAS APPLIED WAS RED AND ITCHY. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE. TOPICAL STEROIDS AND ANTIHISTAMINES WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED TO DATE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE TOPICAL STEROIDS PRESCRIPTION STRENGTH? IS A PHOTO AVAILABLE OF THE PATIENT REACTION? WHAT WAS THE PROCEDURE DATE? WHAT DATE /DAY POST OP WAS THE REACTION NOTED? PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING USED? IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? WERE ANY PATCH OR SENSITIVITY TESTS PERFORMED? PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH; BMI. PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS). HAS THE PATIENT USED OR BEEN EXPOSED TO SIMILAR GLUES/AGENTS FOR REPAIR, CRAFTS, COSMETIC USE (LASHES, NAILS)? CURRENT PATIENT STATUS. PRODUCT NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON THE LEFT KNEE ON AN UNKNOWN DATE IN (B)(6) 2021 AND TOPICAL SKIN ADHESIVE WAS USED. ALLERGIC CONTACT DERMATITIS (ACD) WAS NOTICED IN PATIENT THAT HAD SECOND EXPOSURE TO ADHESIVE. SYMPTOMS INCLUDE ITCHINESS, REDNESS OF SKIN SURROUND THE WOUND. ADHESIVE WAS REMOVED AND PATIENT WAS TREATED WITH TOPICAL STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862903 DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT OMD ETHICON INC. CLR222US 10705031230996

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention