BEUDAMED
    FDA Adverse Event Summary report: N

    UNK Y-MESH

    MDR report key: 2964113 · Received February 8, 2013

    Report

    Report Number
    MW5028967
    Date Received
    February 8, 2013
    Date of Event
    June 25, 2012
    Report Date
    February 8, 2013
    Manufacturer
    UNK
    Product Code
    OTO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ROBOTIC SACROCOLPOPEXY WITH Y-MESH IN 2009 DEVELOPED SYMPTOMS OF MESH EROSION AND VAGINAL IRRITATION AND SURGICAL TREATMENT WAS THEN NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55008 UNK Y-MESH UNK MESH OTO UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization