BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PERIGEE

    MDR report key: 2964102 · Received February 8, 2013

    Report

    Report Number
    MW5028963
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    June 21, 2012
    Report Date
    February 8, 2013
    Manufacturer
    UNK
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT MONARCH TOT SLING AND PERIGEE REINFORCED ANTERIOR REPAIR AND APOGEE REINFORCED RECTOCELE REPAIR IN 2006 SHE STRUGGLED WITH MESH EROSION AND UNDERWENT MOBILIZATION AND CLOSURE OF VAGINA IN 2007. SHE THEN CONTINUED TO HAVE ISSUE WITH MESH EROSION AND CHRONIC VAGINAL DISCHARGE. MESH EXCISION WAS NEEDED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53737 UNK PERIGEE UNK MESH OTP UNK
    53738 UNK MONARCH TOT UNK MESH OTN UNK
    53739 UNK APOGEE UNK MESH OTP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization