BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON TI CLIPS MEDIUM

    MDR report key: 2900882 · Received December 12, 2012

    Report

    Report Number
    3003898360-2012-00604
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 15, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MFR IN TIME FOR THIS REPORT. PHOTO AVAILABLE. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. A VISUAL INSPECTION OF THE PHOTO SHOWED THE PACKAGE TORN/BROKEN. NO OTHER DEFECTS WERE NOTED. ASSESSMENT WAS CONDUCTED AND NO CHARGES REQUIRED. ALTHOUGH FROM THE PICTURE IT WAS OBSERVED THE PACKAGE WAS TORN/DAMAGED, COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF SAMPLE FOR INVESTIGATION. HOWEVER, THE MANUFACTURER WILL CONTINUE TO TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: INCOMING INSPECTION ALLEGED ISSUE: DAMAGED PACKAGE. COMPLAINT FROM DISTRIBUTOR. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON TI CLIPS MEDIUM LIGATING CLIPS FZP TELEFLEX MEDICAL 01E1200160

    Patients

    Seq Age Sex Outcome Treatment
    1