BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KELLY GUM SCS 6-1/4 CV SH

    MDR report key: 3979196 · Received June 2, 2014

    Report

    Report Number
    2523190-2014-00032
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 7, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DOCTOR ORIGINALLY REPORTED DEVICES ARE BROKEN IN THE SAME SPOT. (B)(6) 2014, DOCTOR REPORTS THE TIPS BROKE OFF OF EACH SCISSOR WHILE CUTTING A RETRACTION CORD. HE REPORTED THE TIPS FELL BACK TOWARD THE THROAT AND THE PATIENTS WERE AT RISK OF SWALLOWING IT. TIPS WERE RETRIEVED WITH NO HARM TO THE PATIENTS. DOCTOR HAS NO RECOLLECTION OF EXACT EVENT DATES (ROUGHLY (B)(6)) OR PATIENT AGE/GENDER INFORMATION. PATIENT #2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322250 KELLY GUM SCS 6-1/4 CV SH M5 - GENERAL SURGERY LRW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1