BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANEY CLIPS

    MDR report key: 10396442 · Received August 11, 2020

    Report

    Report Number
    MW5096035
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 10, 2020
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, A PACKAGE OF RANEY CLIPS WAS OPENED ON THE OR TABLE. WHEN THE CONTENTS WERE COUNTED THERE WERE 11 IN THE PACKAGE THAT WAS SUPPOSED TO HOLD 10. DISTRIBUTED BY (B)(4) BUT MANUFACTURED BY INTEGRA LIFE SCIENCES. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858785 RANEY CLIPS APPLIER, SURGICAL, CLIP GDO CODMAN & SHURTLEFF, INC. 070-001 07445

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR