BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED 0.7ML - 12EA

    MDR report key: 15465020 · Received September 22, 2022

    Report

    Report Number
    2210968-2022-07772
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 21, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    UDI-DI
    10705031203532
    PMA / PMN Number
    K152096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). ADDITIONAL INFORMATION PROVIDED: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS DONE TO TREAT THE SHARD PENETRATION? NORMAL PROCEDURE TO TREAT CUTS, IODINE SOLUTION, SIMPLE BANDAGE, CHANGE OF GLOVES. WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED? NO. WAS THERE ANY SPECIAL DIAGNOSTIC TEST PERFORMED? NO. WHAT IS THE STATUS OF THE SURGEON INJURY TODAY? HE IS IN GOOD CONDITION, IT WASN'T A SERIOUS INJURY. WAS IT DIFFICULT TO BREAK THE AMPOULE (WAS EXTRA FORCE NEEDED TO BREAK THE AMPOULE)? NORMAL PRESSURE WAS APPLIED. WAS THE AMPOULE CRUSHED REPEATEDLY? NO. CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED? 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? NOT RETURNED YET. EVALUATION: NO PRODUCT RETURNED. ANALYSIS FOR A PHOTO SUBMITTED TO FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS THE PRODUCT HAD FRAGMENT PENETRATION AND THE AMPOULE CRUSHED AND THE DRY FORMULATION INSIDE THE BULB. THE FILTER IS PURPLE IN COLOR DUE TO CONTACT WITH THE FORMULATION. THE SAMPLE REVEALS A HOLE THROUGH WHICH A GLASS SHARD PROTRUDED INTO THE APPLICATOR BULB. IN ADDITION, A PERFORATION IN THE BUTYRATE TUBE IS OBSERVED. 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 AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND TOPICAL SKIN ADHESIVE WAS USED. THE SURGEON SQUEEZED THE TUBE OF ADHESIVE TO BREAK THE GLASS VIAL, BUT THE TUBE THAT ENCASED IT BROKE AND THE GLASS WAS EXPOSED, CUTTING HIS HAND. TREATED WITH NORMAL PROCEDURE TO TREAT CUTS, IODINE SOLUTION, SIMPLE BANDAGE, CHANGE OF GLOVES. NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661535 DERMABOND ADVANCED 0.7ML - 12EA ADHESIVE, TOPICAL SKIN MPN ETHICON INC. DNX12 10705031203532

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown