BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SU BOX FOR APPLICATION DEVICE 10ML FOR AUSTRALIA NEW ZEALAND

    MDR report key: 11773685 · Received May 4, 2021

    Report

    Report Number
    3003183625-2021-00005
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 7, 2021
    Manufacturer
    TEL-HASHOMER
    Product Code
    MZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 6/15/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. PLEASE CLARIFY WHAT IS MEANT BY "THE APPLICATOR SNAPPED," WAS THE DEVICE BROKEN? YES UPON PREPPING THE DEVICE THE APPLICATOR SNAPPED. 2. IF YES, PLEASE CLARIFY WHICH COMPONENT OF THE KIT WAS BROKEN (BIOLOGICS VIALS OR APPLICATION DEVICE) THE APPLICATION DEVICE WAS BROKEN. ANOTHER WAS OPENED TO COMPLETE THE CASE WITHOUT PATIENT ADVERSE. 3. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? UNFORTUNATELY, NO PICTURES WERE TAKEN. 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). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: EVK10AUS CAN YOU IDENTIFY THE LOT NUMBER OF THE EVICEL APPLICATION DEVICE? WE DON¿T KNOW THE LOT NUMBER. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CLARIFY WHAT IS MEANT BY "THE APPLICATOR SNAPPED," WAS THE DEVICE BROKEN? IF YES, PLEASE CLARIFY WHICH COMPONENT OF THE KIT WAS BROKEN (BIOLOGICS VIALS OR APPLICATION DEVICE) IF NO, PLEASE CLARIFY WHAT WAS THE QUALITY ISSUE EXPERIENCED. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE THE APPLICATOR SNAPPED AS THEY WERE DRAWING UP BIOLOGIC. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668175 SU BOX FOR APPLICATION DEVICE 10ML FOR AUSTRALIA NEW ZEALAND FIBRIN SEALANT PREPARATION DEVICE MZM TEL-HASHOMER

    Patients

    Seq Age Sex Outcome Treatment
    1