BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C1950 - UNO OR/SECUREMENT

    MDR report key: 12445739 · Received September 9, 2021

    Report

    Report Number
    1000317571-2021-00206
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 11, 2021
    Report Date
    August 11, 2021
    Manufacturer
    UNOMEDICAL UK
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 1. COMMON DEVICE NAME: TAPE AND BANDAGE ADHESIVE. PROCODE: KGX (B)(6). NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRODUCT "LEAKS, DOESN'T STICK AND DISINTEGRATES-NOT FIT FOR PURPOSE". MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE TERM DISINTEGRATION. ATTEMPTED TO OBTAIN LOT INFORMATION, UNABLE TO OBTAIN. NO PHOTOGRAPHS RECEIVED DEPICTING THE REPORTED COMPLAINT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348743 L3C1950 - UNO OR/SECUREMENT KGX UNOMEDICAL UK 670M

    Patients

    Seq Age Sex Outcome Treatment
    1