BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP DISH

    MDR report key: 3082656 · Received April 29, 2013

    Report

    Report Number
    8010764-2013-00023
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGERY TIME WAS EXTENDED FORTY-FIVE MINUTES DUE TO PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGERY TIME WAS EXTENDED FORTY-FIVE MINUTES DUE TO INSERTS NOT LOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183741 DEEP DISH GII DISHED INS SZ 3-4 13MM JWH SMITH & NEPHEW, INC. 12DT17993

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 71420770/12HT22242