BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCLIP TRADITIONAL MEDIUM APPLIERS

    MDR report key: 850408 · Received March 2, 2007

    Report

    Report Number
    1044475-2007-00021
    Event Type
    Other
    Date Received
    March 2, 2007
    Report Date
    June 6, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: TELEFLEX MEDICAL REC'D TWO APPLIERS FROM THE FACILITY. THE APPLIERS WERE EVALUATED AND INSPECTED. THE REPORTED ISSUE WAS NOT CONFIRMED. FUNCTIONAL AND VISUAL EXAMINATIONS WERE PERFORMED AND THE APPLIERS MET ACCEPTANCE CRITERIA. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED - CAUSE OF EVENT UNKNOWN. NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FACILITY ALLEGES, DURING THE LIGATION OF FEMORAL VESSELS ON A CANINE, THE CLIPS ARE SLIPPING OFF THE LIGATION SITE. THE FACILITY STATED THAT THE SURGEON WAS UNSURE IF SHE WAS USING THE PROPER CLIP SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCLIP TRADITIONAL MEDIUM APPLIERS LIGATION CLIP APPLIERS GDO TELEFLEX MEDICAL NA 2434872

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention