BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACLIP HEMOCLIP 16MM

    MDR report key: 8469606 · Received April 1, 2019

    Report

    Report Number
    3007216334-2019-00097
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    January 24, 2019
    Report Date
    April 1, 2019
    Manufacturer
    TRANSMED (CHINA) CO LTD
    Product Code
    PKL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: THIS COMPLAINT WAS PREVIOUSLY FILED UNDER 1320894-2019-00030 AS THE MANUFACTURER. IT HAS SINCE BEEN DETERMINED THAT TRANSMED IS THE RESPONSIBLE PARTY, WE ARE THE IMPORTER. (B)(4). DISTRIBUTOR NARRATIVE; THE MANUFACTURER, TRANSMED (B)(4) CO. LTD, IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH (B)(4) CORPORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT: THE (B)(4) REPRESENTATIVE REPORTED THAT DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) THE DOCTOR PLACED 5 CLIPS ON THE ANTRAL BULB DEFECT USING THE DCO235W, 16MM DURACLIP APPLIER. THERE WERE NO REPORTED ISSUES WITH THE INITIAL SURGERY; HOWEVER, THE PATIENT RETURNED A FEW DAYS LATER WITH BLEEDING BECAUSE A FEW OF THE CLIPS FELL OFF. THE PATIENT WAS HOSPITALIZED. FURTHER ATTEMPTS WERE MADE TO FIND OUT WHAT INTERVENTION WERE DONE; HOWEVER, NO OTHER INFORMATION WAS RECEIVED OTHER THAN THE PATIENT'S STATUS IS GOOD. THIS REPORT IS BEING RAISED BASED ON PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261697 DURACLIP HEMOCLIP 16MM HEMOCLIP PKL TRANSMED (CHINA) CO LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other