BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE

    MDR report key: 16397670 · Received February 17, 2023

    Report

    Report Number
    2210968-2023-01215
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 1, 2023
    Report Date
    February 17, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    UDI-DI
    10705031024168
    PMA / PMN Number
    K152490
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL INFORMATION: COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. UNDERSTAND YOU¿RE SEEING REACTION ANYWHERE FROM 4-5 DAYS POST-OPERATIVELY TO 2-3 WEEKS OUT. WHEN DO YOU TYPICALLY REMOVE PRINEO POST-OPERATIVELY? WE TRY TO KEEP THE TAPE ON FOR 3 WEEKS. WHEN WE REMOVE THE PRODUCT, WE ARE DILIGENT TO USE DETACHOL(TM) TO REMOVE GLUE RESIDUE. WE INSTRUCT THE PATIENTS TO ALSO USE GOOGONE(TM) AT HOME THEN SOAP AND WATER. THE GLUE HAS A TENDENCY TO RUN A GREAT DISTANCE WHILE DRYING IF THE TEAM IS LESS DILIGENT IN APPLICATION. ANY DIFFERENCES BY PROCEDURE TYPE? WE ARE SEEING REACTIONS FOR ALL OF OUR PROCEDURES: BREAST REDUCTIONS, LIFTS, RECONSTRUCTIONS, TUMMY TUCKS. THE HIGHEST PREVALENCE IS IN ABDOMINOPLASTIES AS OF LATE. ANY CHANGES AS FAR AS POST-OP CARE? WE HAVE NOT CHANGED ANYTHING AS OF LATE. WE HAVE JUST NOTICED A SEVERE UPTICK IN ALLERGIC REACTIONS. WE HAD 12 IN THE MONTH OF (B)(6). WHAT TYPE OF DRESSING(S) DO YOU CURRENTLY USE, IF ANY, OVER TOP OF PRINEO? SIMPLE DRY STERILE GAUZE (ABD PADS), THEN AN ABDOMINAL BINDER OR SURGICAL BRA. NOTHING ELSE. PATIENTS ARE ALLOWED TO SHOWER WHEN READY. THEY APPLY ABSOLUTELY NO TOPICALS OR LOTIONS. DO YOU HAVE A PROTOCOL IN PLACE PRE-OPERATIVELY TO IDENTIFY ANY POTENTIAL KNOWN HYPERSENSITIVITIES TO THE FOLLOWING: O PRESSURE-SENSITIVE ADHESIVES (ADHESIVE BANDAGES, ATHLETIC TAPE, FIRST-AID TAPE, ETC.) O BENZALKONIUM CHLORIDE (COSMETICS, CLEANING WIPES, ANTIBACTERIAL ADHESIVE BANDAGES, ETC.) O FORMALDEHYDE (PAINTS, VARNISHES, INDUSTRIAL ADHESIVES, ETC.) O CYANOACRYLATE (GLUES, FALSE EYELASHES, FALSE FINGERNAILS, ETC.) YES, WE SPECIFICALLY ASK THEM ALL OF THESE QUESTIONS IN THEIR INTAKE PRIOR TO BEING SEEN. I PERSONALLY ASK IN THE PRE-OP AREA PRIOR TO SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IS PHOTO AVAILABLE OF PATIENT REACTION?; WHAT WAS THE PROCEDURE DATE?; WAS THE TOPICAL STEROID PRESCRIPTION STRENGTH?; PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED; WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE?; 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 LOT OF PRODUCT USED?; CURRENT PATIENT STATUS: WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? ; IF APPLICABLE, WILL PRODUCT BE RETURNED? NO PRODUCT IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH IMPLANTS AND BREAST LIFTS ON AN UNKNOWN DATE IN (B)(6) 2023 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT PRESENTED WITH ALLERGIC REACTION TO ADHESIVE TWO WEEKS POST-OP, AND THE REACTION WAS SO SEVERE THAT SWELLING CAUSED AN EXPOSED IMPLANT. HE HAD TO EMERGENTLY TAKE HER BACK TO THE OPERATING ROOM TO FIX IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119187 DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT OMD ETHICON INC. CLR602US 10705031024168

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention