BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND HV 0.5ML VIAL - 12EA

    MDR report key: 23533930 · Received November 12, 2025

    Report

    Report Number
    2210968-2025-12716
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    January 1, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ADDITIONAL INFORMATION: D9, H3. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. WERE ANY CULTURES TAKEN? RESULTS? NO 2. PLEASE DESCRIBE HOW THE ADHESIVE WAS APPLIED. WHICH ADHESIVE? DERMABOND WAS APPLIED AS PER NORMAL. 3. HOW WAS THE WOUND CLEANED AND DRIED PRIOR TO DERMABOND APPLICATION? WOUND CLEANED AND DRIED AS PER NORMAL. 4. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? NO SPECIAL PREP 5. WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING WAS USED? MEPILEX BORDER. 6. IS THE PATIENT HYPERSENSITIVE OR DO THEY HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? NOT THAT WE KNOW OF. 7. IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? NOT THAT WE KNOW OF 8. WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT IS NOT ALLERGIC TO CYANOACRYLATE, FORMALDEHYDE, BAC, PRESSURE-SENSITIVE ADHESIVE? NO 9. PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH, BMI? OW, F/46, NORMAL BMI AND VK, M/33, NORMAL BMI CHECKING WITH CLINIC TO CONFIRM WHETHER THERE ARE 2 PATIENTS OR 1 PATIENT INVOLVED AS SALES REP WAS ONLY INFORMED OF 1 PATIENT 10. PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS)? NIL 11. HAS THE PATIENT USED OR BEEN EXPOSED TO SIMILAR GLUES/AGENTS FOR REPAIR, CRAFTS, COSMETIC USE (LASHES, NAILS)? NOT THAT WE KNOW OF 12. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? UNKNOWN. 13. PRODUCT CODE AND LOT NUMBER OF PRODUCT USED? AVH12 LOT 1066S5. 14. CURRENT PATIENT STATUS? OKAY AFTER PRESCRIBING STEROID CREAM 15. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? ALLERGY TO DERMABOND/FAULTY DEVICE. INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT A AHV12 DEVICE WAS RETURNED INSIDE IT'S PACKAGE UNOPENED. UPON VISUAL INSPECTION, THE PACKAGING WAS OPENED TO REVIEW THE APPLICATORS AND NO DEFECTS WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED, AND THE APPLICATOR WAS DISPENSED WITHOUT FAILURES OR ISSUES RELATED WITH THE CUSTOMER COMPLIANT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF ETHICON¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. SKIN REACTIONS (I.E., REDNESS, ITCHY RACHES, BLISTERS, ETC) OCCUR AFTER THE USE OF DERMABOND SYSTEM IN A VERY SMALL POPULATION OF PATIENTS. USING THE RECOMMENDATIONS BELOW: DERMABOND SYSTEM SHOULD NOT BE USED IN PATIENTS WITH A KNOWN HYPERSENSITIVITY TO CYANOACRYLATE, FORMALDEHYDE, BENZALKONIUM CHLORIDE (BAC), OR PRESSURE-SENSITIVE ADHESIVES. BECAUSE THESE INGREDIENTS CAN ALSO BE FOUND IN NON-MEDICAL DEVICES SUCH AS HOUSEHOLD OR BEAUTY PRODUCTS, ASK YOUR PATIENT ABOUT ANY PREVIOUS SKIN REACTIONS TO THE FOLLOWING PRODUCTS AS THIS MAY INDICATE A SENSITIVITY TO THE INGREDIENTS IN DERMABOND SYSTEM. (CYANOACRYLATE, FORMALDEHYDE, BENZALKONIUM CHLORIDE BAC, PRESSURE-SENSITIVE ADHESIVES). ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    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/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: WHAT IS THE PROCEDURE NAME? LAPAROSCOPIC CHOLECYSTECTOMY WHAT IS THE PROCEDURE DATE (DD/MM/YYYY)? (B)(6) 2025. WHAT DATE DID THE REACTION OCCUR ON (DD/MM/YYYY)? POD 2. WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? THE RED ITCHY RASHES WERE MAINLY CONTAINED WITHIN THE AREA WHERE DERMABOND WAS APPLIED. DO YOU HAVE ANY PICTURES OF THE REACTION? PFA. IN ADDITION TO STEROID CREAM, WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. NO. DID STEROID CREAM WAS PRESCRIPTION STRENGTH OR BOUGHT OTC? PRESCRIBED WHAT IS THE MOST CURRENT PATIENT STATUS? THE RASHES HAD SETTLED DOWN WITH THE DERMABOND GONE AND AFTER APPLICATION OF STEROID CREAM, HOWEVER THE AFFECTED AREA REMAINS PIGMENTED. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? UNKNOWN TO US. DOES THE PATIENT HAD ANY PRE-EXISTING CONDITION LIKE SENSITIVITY TO THE GLUE COMPONENTS? NOT THAT SHE KNOWS OF WHAT WAS THE CONDITION OF HER WOUND AT THE POINT OF USE? INTACT AND WELL PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. 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. WERE ANY CULTURES TAKEN? RESULTS? PLEASE DESCRIBE HOW THE ADHESIVE WAS APPLIED. HOW WAS THE WOUND CLEANED AND DRIED PRIOR TO DERMABOND 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 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)? WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? PRODUCT CODE AND LOT NUMBER OF PRODUCT USED? CURRENT PATIENT STATUS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT?

    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. ADDITIONAL INFORMATION: D9, H3, H6. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: RE PRESCRIBED STEROID CREAM ¿ COMBIDERM WAS GIVEN. INVESTIGATION SUMMARY- THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THIRTY-FOUR (34) AHV12 DEVICES WERE RETURNED INSIDE IT'S PACKAGE UNOPENED. UPON VISUAL INSPECTION, THE PACKAGING WERE OPENED TO REVIEW THE APPLICATORS AND NO DEFECTS WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED, AND THE APPLICATOR WAS DISPENSED WITHOUT FAILURES OR ISSUES RELATED WITH THE CUSTOMER COMPLIANT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF ETHICON¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. SKIN REACTIONS (I.E., REDNESS, ITCHY RACHES, BLISTERS, ETC) OCCUR AFTER THE USE OF DERMABOND SYSTEM IN A VERY SMALL POPULATION OF PATIENTS. USING THE RECOMMENDATIONS BELOW: DERMABOND SYSTEM SHOULD NOT BE USED IN PATIENTS WITH A KNOWN HYPERSENSITIVITY TO CYANOACRYLATE, FORMALDEHYDE, BENZALKONIUM CHLORIDE (BAC), OR PRESSURE-SENSITIVE ADHESIVES. BECAUSE THESE INGREDIENTS CAN ALSO BE FOUND IN NON-MEDICAL DEVICES SUCH AS HOUSEHOLD OR BEAUTY PRODUCTS, ASK YOUR PATIENT ABOUT ANY PREVIOUS SKIN REACTIONS TO THE FOLLOWING PRODUCTS AS THIS MAY INDICATE A SENSITIVITY TO THE INGREDIENTS IN DERMABOND SYSTEM. (CYANOACRYLATE, FORMALDEHYDE, BENZALKONIUM CHLORIDE BAC, PRESSURE-SENSITIVE ADHESIVES). ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2025 AND A TOPICAL SKIN ADHESIVE WAS USED. ON POST-OP DAYS 2, THE PATIENT EXPERIENCED DARKENING OF SKIN AND DEVELOPED A RASH ALONG THE AREA WHERE THE ADHESIVE WAS APPLIED. THE PATIENT WAS THEN TREATED WITH PRESCRIPTION STEROID CREAM TO CONTROL THE RASH. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228558 DERMABOND HV 0.5ML VIAL - 12EA ADHESIVE, TOPICAL SKIN MPN ETHICON INC. 1066S5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention