BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP PRGRP ANTMCL MSH10X15CM LT

    MDR report key: 3843549 · Received February 11, 2014

    Report

    Report Number
    9615742-2014-00090
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: MESH TORE WHEN INSERTING INTO PATIENT. USED ANOTHER MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90156 LP PRGRP ANTMCL MSH10X15CM LT PROGRIP OTN SOFRADIM PRODUCTION PNH0804

    Patients

    Seq Age Sex Outcome Treatment
    1