BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLING CVT NEEDLE HOLDER

    MDR report key: 866329 · Received June 8, 2007

    Report

    Report Number
    1044475-2007-00029
    Event Type
    Injury
    Date Received
    June 8, 2007
    Date of Event
    October 9, 2000
    Report Date
    June 6, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVAL; THEREFORE, THE IDENTIYY OF THE MFR IS NOT CLEAR. BECAUSE IT WAS ALLEGED THAT THE DEVICE WAS MANUFACTURED BY TELEFLEX MEDICAL, THIS MDR IS BEING FILED UNDER THE TELEFLEX OWNER REGISTRATION NUMBER.

    Description of Event or Problem · 1

    AN ATTORNEY REPRESENTING A CLIENT ALLEGES THAT THE CLIENT WAS DIAGNOSED WITH A PULMONARY HEMORRHAGE FIVE YRS AFTER UNDERGOING A SCHEDULE MYOCARDIAL REVASCULARIZATION. THE ATTORNEY FURTHER ALLEGES THAT THE FOREIGN BODIES FOUND IN THE PT'S LUNG WERE FRAGMENTS OF A PILLING NEEDLE HOLDER THAT MAY HAVE BROKEN OFF DURING SURGERY. THERE WERE SEVERAL FOREIGN BODIES FOUND THAT WERE NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING CVT NEEDLE HOLDER NEEDLE HOLDER GAA TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability