BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRUITT-INAHARA CAROTID SHUNT

    MDR report key: 249928 · Received November 12, 1999

    Report

    Report Number
    1056436-1999-00186
    Event Type
    Other
    Date Received
    November 12, 1999
    Date of Event
    September 1, 1999
    Report Date
    October 14, 1999
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    DQR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 10/14/1999, THE DISTRIBUTOR'S REP INFORMED THE MFR THAT A CUSTOMER IN THEIR TERRITORY EXPERIENCED A PROBLEM WITH THE DEVICE IN QUESTION. IT APPEARS THAT THERE WAS A HOLE IN THE BALLOON. THE DISTRIBUTOR'S REP DID NOT HAVE ALL THE DETAILS ON HAND. THE MFR'S REP FAXED A BLANK PRODUCT COMPLAINT REPORT (PCR) FORM TO THE DISTRIBUTOR'S REP FOR COMPLETION AND WAS REQUESTED TO RETURN THE COMPLETED PCR FORM TO THE MFR UPON COMPLETION. ON 10/18/1999, THE MFR'S REP WAS INFORMED BY THE DISTRIBUTOR'S REP THAT THE BLANK PCR FORM WAS FORWARDED TO THE FACILITY'S BUYER FOR COMPLETION. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT-INAHARA CAROTID SHUNT CATHETER, CANNULA AND TUBING, VASCULAR SHUNT DQR HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other