BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEUKOSTRIP ASS 38X4MM 76X6.4MM CTN 20

    MDR report key: 11741621 · Received April 28, 2021

    Report

    Report Number
    8043484-2021-00985
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 29, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    MZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THIS PRODUCT IS NOT APPROVED IN THE US. THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADHESIVE STRENGTH OF LEUKOSTRIP ASS 38X4MM 76X6.4MM CTN 20 WAS TOO LOW, THEREFORE PRODUCT IS NO RELIABLE. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633051 LEUKOSTRIP ASS 38X4MM 76X6.4MM CTN 20 TOPICAL APPROXIMATION SYSTEM MZR SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1