BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2564828 · Received April 25, 2012

    Report

    Report Number
    9616066-2012-00306
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    January 1, 2012
    Report Date
    April 6, 2012
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2012. (B)(4). (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SET LEAKED. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET FPA CHURCHILL MEDICAL SYSTEMS, INC. 43000E 11111148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK