BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM MSH ADHESIVE

    MDR report key: 23543424 · Received November 13, 2025

    Report

    Report Number
    2210968-2025-12777
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    UDI-DI
    10705031230996
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE ADDITIONAL INFORMATION IS CONFIRMED WITH SALES REP: PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? USING DERMABOND PRINEO CAUSED REDNESS, SWELLING, BLISTERS AND PIGMENTATION AROUND THE WOUND. ¿ PLEASE CLARIFY, WAS THE REACTION PRESENT AFTER THE SHOULDER SURGERY ONLY, OR AFTER THE FOOT FRACTURE AS WELL? ONLY AFTER THE SHOULDER SURGERY. ¿ WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. NO. ¿ IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH. AFTER REMOVING CLR222US, THE DOCTOR PRESCRIBED ANTIBIOTICS OINTMENT FOR TOPICAL USE. ONE WEEK LATER, THE PATIENT VISITED DERMATOLOGY, DERMATOLOGIST PRESCRIBED STEROID, ANTIBIOTICS, AND ANTIHISTAMINE. IT WAS FOUND THAT SEEMS THERE IS PIGMENTATION, THE PATIENT WAS VERY CONCERNED ON THAT AND REPORTED TO THE HEALTH AUTHORITY. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: PLEASE CONFIRM IF THE PRODUCT USED WAS PRINEO OR DERMABOND ADVANCED? SPECIFY WHICH ONE. CONFIRM THERE WAS NO REACTION AFTER THE FOOT SURGERY? WHAT WAS THE SPECIFIC SHOULDER BLADE PROCEDURE? WERE ANY CULTURES TAKEN? RESULTS? PLEASE DESCRIBE HOW THE ADHESIVE WAS APPLIED. HOW WAS THE WOUND CLEANED AND DRIED PRIOR TO PRINEO APPLICATION? WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? DOES THE PATIENT HAVE AN ALLERGY TO THE PREP? WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING WAS USED? IS THE PATIENT HYPERSENSITIVE OR DO THEY HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT IS NOT ALLERGIC TO CYANOACRYLATE, FORMALDEHYDE, BAC, PRESSURE-SENSITIVE ADHESIVE? 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? NAME OF SURGEON? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON THE SHOULDER BLADE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE DOCTOR NOTED REDNESS, SWELLING, SMALL BLISTERS, AND PIGMENTATION AROUND THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985305 DERMABOND PRINEO 22CM MSH ADHESIVE SURGICAL SEALANT OMD ETHICON INC. 1048D3 10705031230996

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention