BEUDAMED
    FDA Adverse Event Summary report: N

    KII 11X100MM SHLD SYS Z-THREADED

    MDR report key: 3032576 · Received March 29, 2013

    Report

    Report Number
    2027111-2013-00106
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 28, 2013
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS NOT KNOW OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROTOMY FOR HARTMANS PROCEDURE: "DURING PROCEDURE (OPEN, NOT LAPAROSCOPIC) A CIRCULAR CLEAR PLASTIC OBJECT WAS DISCOVERED ATTACHED TO THE PT'S OMENTUM. THIS WAS REMOVED AND THE PROCEDURE CONTINUED. THIS ITEM IDENTIFIED BY THE STAFF IN THEIR OPINION TO BE PART OF THE TROCAR." PT STATUS: OK. TYPE OF INTERVENTION: REMOVAL OF THE OBJECT WHICH TOOK PLACE DURING THE ABOVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130276 KII 11X100MM SHLD SYS Z-THREADED NONE GCJ APPLIED MEDICAL RESOURCES CORP. CTB33 1184427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT# INVOLVED IN INCIDENT IS UNK, MAY BE FROM ONE| OF THE FOLLOWING LOTS: 1184427,1181812 AND 1184428