BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM MSH ADHESIVE

    MDR report key: 23209314 · Received October 3, 2025

    Report

    Report Number
    2210968-2025-11322
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 24, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. IS A PHOTO AVAILABLE OF THE PATIENT¿S REACTION? NOT THAT I KNOW OF. PLEASE PROVIDE A DESCRIPTION OF THE EVENT, SYMPTOMS, AND MANIFESTATION OF THE REACTION. SURGEON SAID PATIENT WENT IN FOR A RASH ON THEIR INCISION. (B)(6) ADMITTED PATIENT AND GAVE IV ANTIBIOTICS AND STEROIDS. WHAT WAS THE PROCEDURE DATE? NOT SURE. WHAT DATE /DAY POST OP WAS THE REACTION NOTED? NOT SURE. WHAT MEDICATIONS WERE PRESCRIBED FOR THE PATIENT? ANTIBIOTICS AND STEROIDS. WAS ANY SURGICAL INTERVENTION PERFORMED? NO. WERE ANY CULTURES TAKEN? RESULTS? NOT SURE. PLEASE DESCRIBE HOW THE ADHESIVE WAS APPLIED. PER THE IFU. HOW WAS THE WOUND CLEANED AND DRIED PRIOR TO PRINEO APPLICATION? PER THE IGU. 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? DRY DRESSING. IS THE PATIENT HYPERSENSITIVE OR DO THEY HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? NOT SURE. 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 SURE. PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH, BMI? I DON'T HAVE THAT INFO. PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS)? NOT SURE. 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? NOT SURE. LOT NUMBER OF PRODUCT USED? DON'T HAVE. CURRENT PATIENT STATUS? NOT SURE. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? NOT SURE.

    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. 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. IS A PHOTO AVAILABLE OF THE PATIENT¿S REACTION? PLEASE PROVIDE A DESCRIPTION OF THE EVENT, SYMPTOMS, AND MANIFESTATION OF THE REACTION. WHAT WAS THE PROCEDURE DATE? WHAT DATE /DAY POST OP WAS THE REACTION NOTED? WHAT MEDICATIONS WERE PRESCRIBED FOR THE PATIENT? WAS ANY SURGICAL INTERVENTION PERFORMED? WERE ANY CULTURES TAKEN? RESULTS? PLEASE DESCRIBE HOW 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 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 TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD A REACTION A FEW MONTHS AGO. THE PATIENT WAS ADMITTED AND PUT ON IV STEROIDS AND ANTIBIOTICS FOR THE REACTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319250 DERMABOND PRINEO 22CM MSH ADHESIVE SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention