BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING ESOPHAGEAL DILATOR

    MDR report key: 1033157 · Received April 23, 2008

    Report

    Report Number
    1044475-2008-00009
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    January 18, 2008
    Report Date
    March 27, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED FOR INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. SHOULD DEVICE BECOME AVAILABLE, A DETAILED REVIEW OF THE DEVICE WILL BE PERFORMED.

    Description of Event or Problem · 1

    RECEIVED MEDWATCH REPORT IN 2008. REPORTED AS: "SURGEON INSERTED PILLING DILATOR INTO MOUTH. WHEN SURGEON PULLED INSTRUMENT OUT OF MOUTH, THE RUBBER END OF PILLING DILATION CAME OFF OF INSERTION HANDLE. CUP FORCEPS WERE INSERTED AND SURGEON GRASPED THE TIP AND REMOVED IT." NO FURTHER INFO AVAIL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING ESOPHAGEAL DILATOR ESOPHAGEAL DILATOR KNQ TELEFLEX MEDICAL KK7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA