BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

    MDR report key: 24081651 · Received January 15, 2026

    Report

    Report Number
    2210968-2026-00553
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    November 20, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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: DATE REPORTED -(B)(6) 2026 NAME OF REPORTER (B)(6) (BREAST RECONSTRUCTION NURSE) DATE OF PROCEDURE (B)(6) 2025 DESCRIPTION OF EVENT, SYMPTOMS, MENIFESTATION OF REACTION/INFECTION PRIMARY OPERATION, NO PREVIOUS CHEMO/RADIOTHERAPY. 2 WEEKS POST-OP RASH STARTED COVERING BREASTS, ABDOMEN AND LEGS. PRINEO REMOVED AT THIS POINT, WHEN OBSERVED IN CLINIC. PHOTOS - UNABLE TO RETRIEVE, IF NEEDED, WILL NEED TO FILL OUT REQUEST FOR WHISTON HOSPITAL MEDICAL PHOTOGRAPHY TO RELEASE. NAME OF SURGERY BILATERAL BREAST AUGMENTATION DATE/DAY POST-OP REACTION WAS NOTED 2 WEEKS, VISITED CLINIC (B)(6). ANY PRESCRIPTION STRENGTH MEDICATION PRESCRIBED BETNOVATE WAS THE TOPICAL STEORID PRESCRIPTION STRENGTH? UNKNOWN. WERE ANY OTHER PRESCRIPTION MEDS PRESCRIBED? ANTIHISTAMINES WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN PREVIOUS SURGERY OR WOUND CLOSURE? NO, PRIMARY SURGERY WITH PRINEO PRODUCT CODE/LOT NUMBER - UNKNOWN CURRENT PX STATUS RECOVERED. WAS ANY SURGICAL INTERVENTION PERFORMED? NO. WERE ANY CULTURES TAKEN? NO. HOW WAS THE ADHESIVE APPLIED? UNKNOWN. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? ALL PATIENTS PRE-OPERATIVELY, WASH IN HIBISCRUB/OCTENISAN AND CLEXANE THE NIGHT BEFORE OPERATION. PATIENTS ALSO HAVE PRE-LOAD CARB POWDER. ALL ADMITTED TO SAME WARD. THEATRE PREP UNKNOWN. WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE? NO IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? NO CONFIRMED ALLERGIES. IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? NONE MENTIONED WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT NOT ALLERGIC TO CYANOACRYLATE, FORMALDEHYDE, BAC, PRESSURE-SENSITIVE ADHESIVE? ASKED ABOUT ALLERGIES IN GENERAL, NOT SPECIFIC TO ABOVE. PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH; BMI UNABLE TO RETRIEVE. IF REQUIRED, WILL NEED TO GAIN APPROVAL FROM MATRON FOR RELEASE OF THESE DETAILS. HAS THE PATIENT USED OR BEEN EXPOSED TO SIMILAR GLUES/AGENTS FOR REPAIR, CRAFTS, COSMETIC USE (LASHES, NAILS)? UNKNOWN. NAME OF SURGEON? (B)(6). WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? UNKNOWN. IS PRODUCT AVAILABLE TO RETURN FOR ANALYSIS. NO

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL BREAST AUGMENTATION ON (B)(6) 2025 AND A TOPICAL SKIN ADHESIVE WAS USED. PRIMARY OPERATION. TWO WEEKS POST-OP, A RASH STARTED COVERING THE BREASTS, ABDOMEN AND LEGS. THE PATIENT VISITED THE CLINIC ON (B)(6) 2025. THE SKIN ADHESIVE WAS REMOVED AT THIS POINT, WHEN OBSERVED IN CLINIC. THE PATIENT WAS PRESCRIBED THE MEDICATION BETNOVATE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141407 PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention