BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED 0.7ML - 12EA

    MDR report key: 23265092 · Received October 10, 2025

    Report

    Report Number
    2210968-2025-11629
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K152096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM THE PROCEDURE THAT WAS PERFORMED IN THE PHOTO PROVIDED FOR PATIENT 1. THORACIC. I DO NOT KNOW EXACTLY FOR EACH PATIENT, PLEASE PROVIDE THE FOLLOWING INFORMATION: NAME OF EACH SURGICAL PROCEDURE. I DO NOT KNOW PLEASE DESCRIBE HOW THE ADHESIVE WAS APPLIED. AFTER THE SKIN WAS CLEANED AND DRIED HOW WAS THE WOUND CLEANED AND DRIED PRIOR TO DERMABOND APPLICATION? YES. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? CHLORAPREP WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING WAS USED? NOT SURE. IS THE PATIENT HYPERSENSITIVE OR DO THEY HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IN SPEAKING TO THE SURGEON, HE WAS NOT AWARE. IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? NOT SURE WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT IS NOT ALLERGIC TO CYANOACRYLATE, FORMALDEHYDE, BAC, PRESSURE-SENSITIVE ADHESIVE? NOT TO MY KNOWLEDGE PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH, BMI? (PLEASE REFER TO THE ATTACHED EMAIL) NOT SURE OF THE OTHER PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS)? DO NOT KNOW HAS THE PATIENT USED OR BEEN EXPOSED TO SIMILAR GLUES/AGENTS FOR REPAIR, CRAFTS, COSMETIC USE (LASHES, NAILS)? NOT SURE. WAS PRINEO, DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? NO. CURRENT PATIENT STATUS? PATIENT NOW DOING WELL. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? HE IS NOT SURE. HE HAS HAD ONLY ON ISSUE IN A DECADE AND THAT IS THE ONE WE ARE WRITING ABOUT NOW. IS PRODUCT AVAILABLE TO RETURN FOR ANALYSIS? NO.

    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 LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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? THESE ARE PROCEDURE PERFORMED BY THORACIC SURGEONS. WHAT IS THE PROCEDURE DATE? MY APOLOGIES, I DO NOT HAVE THE DATES OF THE PROCEDURES. I'VE ONLY SPOKEN TO ONE SURGEON ABOUT IT WHO HAD ONE ISSUE WITH ONE PATIENT AT EVERY PORT SITE THERE WAS SCARRING. WHAT DATE DID THE REACTION OCCUR ON? I DO NOT HAVE THE PROCEDURE DATE. THIS WAS BROUGHT TO MY ATTENTION. WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? I HAVE A PICTURE TO SHARE WITH YOU, IT BASICALLY LOOKS LIKE A RASH SURROUNDING EVERY PORT SITE. DO YOU HAVE ANY PICTURES OF THE REACTION? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. THERE WAS NEVER A RE-OPERATION, THEY DID ASK THESE PATIENT TO PEEL OFF THE DERMABOND. AND HIS WOUNDS ARE HEALING. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH. WHAT IS THE MOST CURRENT PATIENT STATUS? THEY PROVIDED STEROIDS IN THAT SEEM TO. CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED? THE PRODUCT CODE IS DNX 12. I DO NOT HAVE A LOT. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? I AM NOT AWARE. DR. SAID HE WOULD INVESTIGATE FURTHER THE REACTIONS THAT HIS PARTNERS HAVE HAD 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 THE PROCEDURE THAT WAS PERFORMED IN THE PHOTO PROVIDED FOR PATIENT 1. FOR EACH PATIENT PLEASE PROVIDE THE FOLLOWING INFORMATION: NAME OF EACH SURGICAL PROCEDURE. 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? CURRENT PATIENT STATUS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? IS PRODUCT AVAILABLE TO RETURN FOR ANALYSIS?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY BY A THORACIC SURGEON ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD A SKIN REACTION THAT LOOKED LIKE A RASH. THE PATIENT PEELED OFF THE TOPICAL SKIN ADHESIVE AND THE WOUND IS HEALING. THE SURGEON PROVIDED STEROIDS. THIS HAPPENED LAST MONTH. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315490 DERMABOND ADVANCED 0.7ML - 12EA ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention