BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO

    MDR report key: 15659445 · Received October 21, 2022

    Report

    Report Number
    MW5112812
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 19, 2022
    Manufacturer
    ETHICON - 3M / ETHICON, INC.
    Product Code
    OMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACUTE NECROTIZING DERMATITIS AFTER USE OF DERMABOND PRINEO. ON (B)(6) 2022 75 YEAR OLD HAVE RIGHT TOTAL KNEE ARTHROPLASTY AT THE (B)(6) HOSPITAL. WOUND CLOSED WITH SUB CIRCULAR SUTURES, WOUND MESH AND DERMABOND PRINEO GLUED. ON (B)(6) 2022 ENTIRE RIGHT LEG PRURITUS AND ERYTHEMATOUS WOUND CARE GIVEN. SEVERE BLISTERED RASH NOTED IN AREA 5X12 AROUND INCISION. PROFOUND RASH AND PRURITUS. LESION ¿PROPAZAFID BY NON-EXPOSED SITES." ENCLOSED PHOTOS DO NOT DEFINE THE DEGREE OF REDNESS OR BLACKENED AREAS. IT IS KNOWN THAT A PREVIOUS EXPOSURE CAN SENSITIZE PATIENT AND RESULT IN FUTURE EXPOSURE RASH. SKIN TESTING PRETREATMENT CAN ITSELF BE SENSITIZING. THIS DRUG IS MUTILATING TO THOSE WHO HAVE ALLERGIC RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762351 DERMABOND PRINEO CUTANEOUS TISSUE ADHESIVE WITH MESH OMD ETHICON - 3M / ETHICON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention BYSTOLIC 5MG/DL| CRESTOR 10/DL| SYNTHROID 0.088/DL| TYLENOL PRN