BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED 0.7ML - 6EA

    MDR report key: 12087446 · Received June 29, 2021

    Report

    Report Number
    2210968-2021-05922
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 31, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 7/28/2021. CORRECTED DATA: B3, H6 REMOVE E040203 LOCAL REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND OBTAINED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE PROCEDURE NAME? PERIAREOLAR AUGMENTATION MAMMAPLASTY. WHAT IS THE PROCEDURE DATE? (B)(6) 2021. WHAT DATE DID THE EVENT OCCUR ON? ON THE DAY OF THE PROCEDURE. PLEASE CLARIFY, DID THE PATIENT EXPERIENCE A SKIN REACTION TO THE DERMABOND? NO SKIN REACTION/IRRITATION WAS OBSERVED. IF SO, WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? DO YOU HAVE ANY PICTURES OF THE REACTION? NO SKIN REACTION WHEN APPLYING DERMABOND. HOWEVER THE ADHESIVE STARTED TO SOLIDIFY SOON AFTER THE TUBE WAS OPENED, BEFORE FULLY APPLIED TO THE WOUND. (IT¿S UNLIKELY THAT THE CLINIC CAN GET APPROVAL TO RELEASE PICTURES OF THE PROCEDURES.) WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. USED A SECOND TUBE OF DERMABOND FOR RE-CLOSURE ON THE DAY OF THE PROCEDURE IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIBED OR PURCHASED OVER-THE-COUNTER. MEDICATION WAS NOT NEEDED. WHAT IS THE MOST CURRENT PATIENT STATUS? WOUND HAS HEALED. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? PATIENT HAD NOT USED SKIN ADHESIVE BEFORE. H3 EVALUATION: THE ANALYSIS RESULTS FOUND THAT DEVICES WERE RETURNED INSIDE OF THE STERILE PACKAGING UNOPENED. UPON VISUAL INSPECTION, THE SAMPLE WAS OBSERVED TO BE CONFORMING ACCORDING TO MANUFACTURING SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 1

    (B)(4). ADDITIONAL INFORMATION PROVIDED: AND ALSO CONFIRMED WITH THE DOCTOR HOLDING THE KNIFE AND BRUSHING THE HAND BEFORE THAT THE GAUZE WILL BE COVERED FOR PROTECTION AFTER THE GLUE DRIES. THE PATIENT IS AFFECTED AND UNABLE TO BATHE NORMALLY. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE PROCEDURE NAME? WHAT IS THE PROCEDURE DATE? WHAT DATE DID THE EVENT OCCUR ON? PLEASE CLARIFY, DID THE PATIENT EXPERIENCE A SKIN REACTION TO THE DERMABOND? IF SO, WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? DO YOU HAVE ANY PICTURES OF THE REACTION? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIBED OR PURCHASED OVER-THE-COUNTER. WHAT IS THE MOST CURRENT PATIENT STATUS? WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? IS THE PRODUCT INVOLVED IN THE EVENT OR A REPRESENTATIVE SAMPLE (PRODUCT FROM THE SAME LOT NUMBER) AVAILABLE FOR EVALUATION? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT REPORTED ABNORMAL REACTION TO THE CLINIC. ABOUT THE THIRD DAY, THERE WILL BE DEGUMMING, AND THE WOUND CANNOT BE ADHERED, RESULTING IN EXUDATE. GAUZE COVERED FOR PROTECTION AFTER THE GLUE DRIES. THE PATIENT RETURNED TO THE CLINIC TO REFILL THE ADHESIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980552 DERMABOND ADVANCED 0.7ML - 6EA ADHESIVE, TOPICAL SKIN MPN ETHICON INC. QPBAKD

    Patients

    Seq Age Sex Outcome Treatment
    1