BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I

    MDR report key: 8420818 · Received March 14, 2019

    Report

    Report Number
    3006425876-2019-00186
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 22, 2019
    Report Date
    February 26, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED MFR REPORT NUMBER: THE INITIAL MDR REPORT WAS MISTAKENLY SUBMITTED UNDER MFR# 3006425876-2019-00186. THE CORRECT MFR# IS 3011137372-2019-00145, WHICH IS STATED ON THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONCE THE THREAD WAS INSERTED, THE DEVICE BROKE WHEN THE SURGEON REMOVED THE EFX. THE PLASTIC COVER ON THE UPPER PART OF THE TRIANGLE BROKE. IT WAS DIFFICULT TO REMOVE THE DEVICE. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONCE THE THREAD WAS INSERTED, THE DEVICE BROKE WHEN THE SURGEON REMOVED THE EFX. THE PLASTIC COVER ON THE UPPER PART OF THE TRIANGLE BROKE. IT WAS DIFFICULT TO REMOVE THE DEVICE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216489 COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I GAT TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1