BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM MSH ADHESIVE

    MDR report key: 23439566 · Received October 31, 2025

    Report

    Report Number
    2210968-2025-12408
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    January 1, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    UDI-DI
    10705031230996
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: THEY TOOK ALL THE PRINEO OFF THE PATIENTS. TREATED THEM. AND SWITCHED TO ANOTHER PRODUCT. WE LOST THE BUSINESS. THEY DIDN¿T GIVE ME ANY OTHER DETAILS.

    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. 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: SPECIALTY: NEUROSURGERY. PROCEDURES: LUMBAR FUSIONS. I JUST SPOKE WITH THE NP AND ONE OF THE ATTENDINGS. THEY HAVE USED PRINEO EXCLUSIVELY ON ALL OF THEIR LUMBARS IN NEURO FOR A LONG TIME. THERE ARE 3 AREAS PRINEO COULD BE PLACED BASED ON ACCESS IN THESE PROCEDURES. 1. DORSAL. 2. LATERAL. 3. VENTRAL (ANTERIOR APPROACH BY GENERAL SURGEON). IN THE 30 DAYS THEY HAVE HAD 5-7 PATIENTS COME BACK WITH TERRIBLE REACTIONS. THE PRINEO IS NOT DISCRIMINATING ON AREA OF ACCESS OR PATIENT TYPE. THE HOSPITAL HAS NOT CHANGED STERILE PREP. THEY ARE WIPING THE BETADYNE OFF WITH A WET LAP AND THEN DRYING BEFORE THEY PUT THE PRINEO ON. THEY ARE USING A THIN LAYER OF ACTIVATOR AND WIPING OFF EXCESS. THE PATIENTS ARE ALL REACTING WITHIN 48-72 HOURS. THEY ARE REMOVING THE PRINEO IN THE OFFICE WITH VASOLINE AND SKIN STAPLING THE PATIENTS (IN A STERILE SET UP). A COUPLE OF THE PATIENTS ENDED UP AT DERMATOLOGISTS. AND SOME ARE STILL EXPERIENCING ISSUES WITH SKIN HEALING WHERE THE PRINEO WAS PLACED. NOT AT THE INCISION BUT UNDER THE PRINEO ITSELF ON HEALTHY EPIDERMAL LAYER. THE SURGEON SAYS, ¿IT¿S LIKE IT¿S A CHEMICAL BURN¿. THEY ARE ASKING ¿DID ETHICON CHANGE ANYTHING WITH THE FORMULATION?¿ WE DO NOT HAVE LOT NUMBERS IN THIS SITUATION. THEY ARE TRYING TO DECIDE AS A PRACTICE IF THEY WANT TO CONTINUE USING PRINEO. THEY SAID IT¿S PHENOMENAL FOR INFECTION PREVENTION BUT THE REACTIONS ARE SO SEVERE IT¿S HAVING THEM TO THINK ABOUT CHANGING THEIR PROTOCOL. THERE ARE NO LOT NUMBERS RECORDED ON THE PRINEO BUT WITH ALL 6 PATIENTS, THE SAME TYPE OF REACTION OCCURRED. DATES: ALL IN SEPTEMBER AND EARLY OCTOBER. THE PREP USE FOR EACH OF THESE PATIENTS WAS CHLORAPREP AND BETADYNE WET PREP TRAY. WE DID UNCOVER THAT THERE IS NO REMOVAL PROCESS OF THE PREP PRIOR TO PUTTING ON THE PRINEO. THE REACTIONS WERE HAPPENING TO EVERY SKIN TYPE. THEY ALSO SCREEN FOR CYANOACRYLATE ALLERGIES. THESE PARTICULAR REACTIONS WOULD OCCUR WITHIN A DAY OR TWO SO THEY WOULD HAVE TO REMOVE THE PRINEO AND THEN IT WOULD SPREAD ACROSS THE SKIN OVER WEEKS. SOME PATIENTS ENDED UP AT THE DERMATOLOGIST. WHEN THEY COLLECTED THE DATA OF PRINEO PATIENTS OVER THAT TIMEFRAME. IT ACCOUNTED FOR A 13% REACTION OCCURRENCE. THEY ALSO SAID THESE REACTIONS WERE BURN LIKE. THE LOCATIONS OF THE PRINEO WERE DORSAL VENTRAL AND LATERAL. THEY HAVE USED PRINEO FOR A LONG TIME ALONG WITH THIS PREP. AS A RESOLUTION I RECOMMENDED WAYS TO REMOVE THE BETADYNE AND CHG IN THE CHLORAPREP PRIOR TO APPLYING TO PRINEO. THEY ARE TO TRY THAT AND SEE IF WE CAN REDUCE THE SKIN REACTION SEVERITY AND QUANTITY. 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: WAS ANY PRESCRIPTION STRENGTH MEDICATION PRESCRIBED? PLEASE SPECIFY? WERE ANY CULTURES TAKEN? RESULTS? 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? 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?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR FUSION ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT PRESENTED WITH SEVERE REACTIONS ON THE EPIDERMIS. IT'S LIKE A CHEMICAL BURN. THE REACTION OCCURRED WITHIN A DAY OR TWO AND THEY REMOVED THE TOPICAL SKIN ADHESIVE AND THEN THE REACTION SPREAD ACROSS THE SKIN OVER WEEKS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563255 DERMABOND PRINEO 22CM MSH ADHESIVE SURGICAL SEALANT OMD ETHICON INC. 10705031230996

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention