BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING LEMOLE-PILL VALVE RET SET #1

    MDR report key: 2901473 · Received January 3, 2013

    Report

    Report Number
    1044475-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 11, 2012
    Manufacturer
    TELEFLEX
    Product Code
    EIG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE RECEIVED MY MFR, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: CUSTOMER ALLEGES THAT THE CLAMPS WOULDN'T STAY TIGHT DURING A PROCEDURE. STAFF HAD TO KEEP RE-TIGHTENING THE CLAMPS. NO PT INJURY REPORTED. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458 PILLING LEMOLE-PILL VALVE RET SET #1 RETRACTOR EIG TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1