BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIO2MESH

    MDR report key: 4605881 · Received February 20, 2015

    Report

    Report Number
    3009749957-2015-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 1, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BIOCER ENTWICKLUNGSGMBH
    Product Code
    OXJ
    PMA / PMN Number
    K113311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BIOCER B)(4) HAS BEEN INFORMED BY (B)(4), DIVISION MEDICAL DEVICES, (B)(4) ON A POTENTIAL COMPLICATION USING TIO2MESH SURGICAL MESH IMPLANTS. IN A FEW EXCEPTIONAL CASES AND ONLY UNDER CERTAIN CONDITIONS IT CAN HAPPEN THAT AFTER AN INCISION PARALLEL TO THE BLUE ORIENTATION STRIPES A SO-CALLED LADDER IS FORMED AND A PROPAGATION OF THE TEAR WITHOUT ANY FORCE EFFECT WILL RESULT. THE PROBLEM IS NOTED PRIOR USE OF THE DEVICE. TO PREVENT THIS EVENTUALITY IN FUTURE, BIOCER EXTENDS THE INSTRUCTIONS FOR USE OF TIO2MESH WITH A WARING: INCISIONS AND CAVITIES PARALLEL TO THE BLUE ORIENTATION STRIPES SHOULD GENERALLY BE AVOIDED. FOR INDICATIONS IN WHICH AN INCISION IS REQUIRED SPECIALLY MANUFACTURED MESH IMPLANTS ARE PROVIDED BY THE MANUFACTURER. BIOCER HAS ALREADY RECEIVED THE NCAR FROM (B)(4). CONSIDERS THIS CORRECTIVE ACTION TO BE SUFFICIENT FOR RISK REDUCTION. THE PRODUCT TIO2MESH IS NOT YET DISTRIBUTED IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122303 TIO2MESH SURGICAL MESH IMPLANT OXJ BIOCER ENTWICKLUNGSGMBH MFP111 130928

    Patients

    Seq Age Sex Outcome Treatment
    1