BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND UNKNOWN PRODUCT

    MDR report key: 21970318 · Received May 6, 2025

    Report

    Report Number
    2210968-2025-04956
    Event Type
    Injury
    Date Received
    May 6, 2025
    Report Date
    May 20, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE ¿ WHAT IS THE PROCEDURE NAME? LEFT ARTHROPLASTY TOTAL KNEE ROBOT ASSISTED. ¿ WHAT IS THE PROCEDURE DATE? (B)(6) 2024. ¿ WHAT DATE DID THE REACTION OCCUR ON? ¿ WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? ¿ DO YOU HAVE ANY PICTURES OF THE REACTION? YES. ¿ WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. ZYRTEC AND HYDROCORTISONE AND PRESCRIPTION OF KEFLEX. ¿ IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH. ¿ WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? YES, SPINAL ABDUCTOR ON (B)(6) 2022. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT DATE /DAY POST OP WAS THE REACTION NOTED? WAS ANY SURGICAL INTERVENTION PERFORMED? WERE ANY CULTURES TAKEN? RESULTS? PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED. 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 USED? IS THE PATIENT HYPERSENSITIVE OR 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 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)? PRODUCT CODE AND/OR LOT OF PRODUCTS USED? 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. NO PRODUCT AVAILABLE FOR RETURN. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PER CUSTOMER: I ALREADY PROVIDED MY RESPONSE. WHAT DATE /DAY POST OP WAS THE REACTION NOTED? WAS ANY SURGICAL INTERVENTION PERFORMED? WERE ANY CULTURES TAKEN? RESULTS? PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED. 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 USED? IS THE PATIENT HYPERSENSITIVE OR 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 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)? PRODUCT CODE AND/OR LOT OF PRODUCT USED? 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. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT ARTHROPLASTY TOTAL KNEE ROBOT ASSISTED PROCEDURE ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. A PATIENT THAT EXPERIENCED A SKIN REACTION TO ADHESIVE. TREATED WITH ZYRTEC, HYDROCORTISONE AND PRESCRIPTION OF KEFLEX. NO FURTHER INFORMATION WAS PROVIDED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66723 DERMABOND UNKNOWN PRODUCT ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention