BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE

    MDR report key: 13487887 · Received February 8, 2022

    Report

    Report Number
    2210968-2022-00920
    Event Type
    Injury
    Date Received
    February 8, 2022
    Report Date
    February 8, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    UDI-DI
    10705031230996
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    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. PLEASE PROVIDE PHOTOS OF PATIENT REACTION/INFECTION? WHAT WAS THE PROCEDURE DATE? WHAT DATE /DAY POST OP WAS THE PRINEO REMOVED? WHAT DATE /DAY POST OP WAS THE REACTION/INFECTION NOTED? 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? WAS ANY TYPE MEDICATION PRESCRIBED TO TREAT REACTION/INFECTION? TYPE/ DOSAGE PRESCRIBED? WERE ANY CULTURES TAKEN? RESULTS? IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? WERE ANY PATCH OR SENSITIVITY TESTS PERFORMED? 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. NO PRODUCT IS AVAILABLE FOR RETURN. 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. PLEASE PROVIDE PHOTOS OF PATIENT REACTION/INFECTION? WHAT WAS THE PROCEDURE DATE? WHAT DATE /DAY POST OP WAS THE PRINEO REMOVED? WHAT DATE /DAY POST OP WAS THE REACTION/INFECTION NOTED? 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? WAS ANY TYPE MEDICATION PRESCRIBED TO TREAT REACTION/INFECTION? TYPE/ DOSAGE PRESCRIBED? WERE ANY CULTURES TAKEN? RESULTS? IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? WERE ANY PATCH OR SENSITIVITY TESTS PERFORMED? 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. NO PRODUCT IS AVAILABLE FOR RETURN. 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 AN UNKNOWN CARDIAC PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. POST-OP FIVE TO TEN DAYS, PATIENT CAME IN FOR A VISIT AND WHILE REMOVING THE ADHESIVE, IT WAS NOTICED THAT THE PATIENT HAD SOME REDNESS AROUND THE APPLICATION, PRIOR TO REMOVAL. ABOUT A WEEK OR TWO AFTER REMOVAL A ¿GREEN LIKE MOSS¿ FORMED WHERE THE ADHESIVE ONCE WAS. WOUND DEBRIDEMENT WAS DONE TO CLEAR UP THE ¿GREEN MOSS LIKE¿ THAT FORMED. PATIENT CURRENTLY DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. POST-OP FIVE TO TEN DAYS, PATIENT CAME IN FOR A VISIT AND WHILE REMOVING THE ADHESIVE, IT WAS NOTICED THAT THE PATIENT HAD SOME REDNESS AROUND THE APPLICATION, PRIOR TO REMOVAL. ABOUT A WEEK OR TWO AFTER REMOVAL A ¿GREEN LIKE MOSS¿ FORMED WHERE THE ADHESIVE ONCE WAS. WOUND DEBRIDEMENT WAS DONE TO CLEAR UP THE ¿GREEN MOSS LIKE¿ THAT FORMED. PATIENT CURRENTLY DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903481 DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT OMD ETHICON INC. CLR222US 10705031230996

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention