BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM MSH ADHESIVE

    MDR report key: 23149722 · Received September 25, 2025

    Report

    Report Number
    2210968-2025-11038
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED SURGERY (B)(6). REACTION OCCURRED (B)(6). REMOVAL OF TAPE ON (B)(6) + BENEDRYL 50 MG QHS + MEDROL DOSE PACK. IMPROVED ON F/U VISIT FOLLOWING COMPLETION OF STEROID TAPER. ALLERGIC REACTION CONFINED TO THE AREA OF THE PRINEO TAPE, , SEVERE PRURITUS SMALL BLISTERING. NO PRIOR USE, H/O SKIN SENSITIVITY TO OTHER ADHESIVES (BAND-AIDS ETC.) ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHEN WAS THE PRINEO PRODUCT REMOVED FROM THE PATIENT? WERE ANY CULTURES TAKEN? RESULTS? PLEASE DESCRIBE HOW WAS 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? 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? WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT 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)? WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? PRODUCT LOT OF PRODUCTS USED? CURRENT PATIENT STATUS. NAME OF SURGEON? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? IS PRODUCT AVAILABLE TO RETURN FOR ANALYSIS. NO PRODUCT IS AVAILABLE FOR RETURN. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE SURGERY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT WAS FOUND WITH IRRITATION AT 2-WEEK POST OP CHECK. DEVICE AVAILABILITY: UNKNOWN. REACTION OCCURRED (B)(6) 2025, REMOVAL OF TAPE ON (B)(6) AND BENEDRYL 50 MG QHS + MEDROL DOSE PACK. IMPROVED ON FOLLOW UP VISIT FOLLOWING COMPLETION OF STEROID TAPER. ALLERGIC REACTION CONFINED TO THE AREA OF THE ADHESIVE TAPE, SEVERE PRURITUS SMALL BLISTERING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765363 DERMABOND PRINEO 22CM MSH ADHESIVE SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention