BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING CORONARY SCISSORS 7"

    MDR report key: 1639343 · Received March 15, 2010

    Report

    Report Number
    1044475-2010-00016
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 23, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    LRR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DEVICE HAS A ROUGH SQUARE FINISH TO THE TIPS. IT WAS REPORTED THAT THE DEVICE WAS NOT USED DURING A MEDICAL PROCEDURE OR DURING TREATMENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING CORONARY SCISSORS 7" CORONARY SCISSORS LRR TELEFLEX MEDICAL NA RR2

    Patients

    Seq Age Sex Outcome Treatment
    1