BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT 35W 6/BOX

    MDR report key: 3834611 · Received March 19, 2014

    Report

    Report Number
    3003898360-2014-00206
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    ALLEGED ISSUE: SKIN STAPLER BLOCKED DURING SKIN CLOSURE AT THE END OF 7 TO 8 CLIPS. NO PT INJURY REPORTED. PT CONDITION LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163297 WECK VISISTAT 35W 6/BOX SKIN STAPLER GAG TELEFLEX 01B1300459

    Patients

    Seq Age Sex Outcome Treatment
    1