BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE

    MDR report key: 15704990 · Received October 31, 2022

    Report

    Report Number
    2210968-2022-08973
    Event Type
    Injury
    Date Received
    October 31, 2022
    Date of Event
    September 7, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    UDI-DI
    10705031237339
    PMA / PMN Number
    K133864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL INFORMATION PROVIDED: DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES? YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFLAMMATION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, DOCTOR HAS BEEN USING STRATAFIX AND DERMABOND PRINEO ON ALL HIS TKA & THA ORTHOPEDIC CASES SINCE 2017. HE UNDERSTANDS THE CLINICAL VALUE OF OUR HIGHEST TECHNOLOGY WOUND CLOSURE PRODUCTS. THE PA HAS BEEN TRAINED MULTIPLE TIMES ON THE APPLICATION DURING LOCAL EDUCATION COURSES. AND I HAVE WITNESSED MULTIPLE CASES OF CORRECT APPLICATION. THEY ALWAYS ASK IF PATIENTS HAVE ANY ADHESIVE OR GLUE ALLERGIES, AND FOLLOW NEW PROTOCOLS IF YES. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS STRATFIX USED ON ANY OF THE THREE EVENTS BEING REPORTED? IF YES, WAS THERE ANY ISSUES REPORTED FROM THE STRATAFIX ADMINISTRATION? YES AND NO ISSUES REPORTED FROM THE STRATAFIX ADMINISTRATIONS OR THOSE TISSUE LAYERS. WHAT IS THE PROCEDURE DATE? (B)(4), (B)(6) 2022. WHAT DATE DID THE REACTION OCCUR ON? (B)(4), (B)(6) 2022 - DAY AFTER. ARE ANY PICTURES OF THE REACTIONS AVAILABLE FOR THE OTHER TWO PATIENTS? NO, NOT A BIG CONCERN TO THE SURGEON. HE HAS SEEN THESE SKIN REACTIONS BEFORE. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED FOR ANY OF THE THREE EVENTS (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. REMOVAL AND PRESCRIPTION MEDICATION TO DECREASE THE INFLAMMATION INCLUDING STEROIDS. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH - YES PRESCRIPTION STRENGTH. WHAT IS THE MOST CURRENT PATIENT STATUS? HEALTHY AND HEALED. CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED - LOT - SGBDTJ. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? NO. IS THE PRODUCT INVOLVED IN THE EVENT OR A REPRESENTATIVE SAMPLE (PRODUCT FROM THE SAME LOT NUMBER) AVAILABLE FOR EVALUATION? IF YES, WHAT IS THE DEVICE RETURN STATUS? YES ALL LOTS, NOTED ABOVE, HAVE BEEN RETURNED. WAS STRATFIX USED ON ANY OF THE THREE EVENTS BEING REPORTED? IF YES, WAS THERE ANY ISSUES REPORTED FROM THE STRATAFIX ADMINISTRATION? YES AND NO ISSUES REPORTED FROM THE STRATAFIX ADMINISTRATIONS OR THOSE TISSUE LAYERS. PHOTOS AVAILABLE. YES. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED FOR ANY OF THE THREE EVENTS (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. REMOVAL AND PRESCRIPTION MEDICATION TO DECREASE THE INFLAMMATION INCLUDING STEROIDS. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH - YES PRESCRIPTION STRENGTH. WHAT IS THE MOST CURRENT PATIENT STATUS? HEALTHY AND HEALED. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? NO. PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED - IN A BRUSHING, PAINTING MOTION. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? NO PRE. JUST CLEAN AND DRY SKIN WITH SALINE. WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING USED? DRY COVIDIEN DRESSING. IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? NOT THAT HE WAS AWARE OF. IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? NOT THAT HE WAS AWARE OF. WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT NOT ALLERGIC TO CYANOACRYLATE, FORMALDEHYDE, BAC, PRESSURE-SENSITIVE ADHESIVE? YES. PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH; BMI - BOTH WERE MALE, MID 50'S, 35 BMI. PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS) - NOT THAT HE WAS AWARE OF. HAS THE PATIENT USED OR BEEN EXPOSED TO SIMILAR GLUES/AGENTS FOR REPAIR, CRAFTS, COSMETIC USE (LASHES, NAILS)? UNSURE. EVALUATION: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE VISUAL ANALYSIS REVEALED THAT ONE DEVICE WAS RETURNED INSIDE OF THE STERILE PACKAGING UNOPENED. UPON VISUAL INSPECTION, THE PACKAGING WAS OPENED TO REVIEW THE APPLICATOR AND NO ANOMALIES OR DEFECTS WERE OBSERVED. THE SAMPLE WAS OBSERVED ACCORDING TO MANUFACTURING SPECIFICATIONS. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. CONCOMITANT PRODUCT: STRATAFIX UNKNOWN. RELATED EVENTS CAPTURED VIA MW# 2210968-2022-08972, MW# 2210968-2022-08974. 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). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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 TOTAL KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022 AND TOPICAL SKIN ADHESIVE WAS USED. POST OP, THE PATIENT HAD A REACTION. ADHESIVE WAS REMOVED AND PRESCRIPTION MEDICATION TO DECREASE THE INFLAMMATION INCLUDING STEROIDS. CURRENT PATIENT STATUS IS HEALTHY AND HEALED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512145 DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT OMD ETHICON INC. CLR222 SGBDTJ 10705031237339

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention STRATAFIX UNKNOWN.