BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLEY STERNUM RETRACTOR

    MDR report key: 436181 · Received January 2, 2003

    Report

    Report Number
    2515651-2002-00017
    Event Type
    Malfunction
    Date Received
    January 2, 2003
    Report Date
    August 3, 2002
    Manufacturer
    PILLING SURGICAL
    Product Code
    FFO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE COOLEY STERNUM RETRACTOR BROKE DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLEY STERNUM RETRACTOR SELF-RETAINING RETRACTOR FFO PILLING SURGICAL 34-1195 VV0

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention