BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS PERIGEE SYSTEM

    MDR report key: 3852124 · Received June 5, 2014

    Report

    Report Number
    2183959-2014-00197
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 8, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2008.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT NO.: 2183959-2014-00196, 2183959-2014-00198, 2183959-2014-00199, 2183959-2014-00200. IT WAS REPORTED THE PATIENT HAD HER PERIGEE GRAFT REVISED IN (B)(6) 2008. IT WAS FURTHER NOTED THE PATIENT WAS USING ESTROGEN CREME. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED VAGINAL PAIN AND POST COITAL BLEEDING. THE REVISION SURGERY WAS ON (B)(6) 2008 THAT INCLUDED 1 CM TRIM OF MESH EROSION, MOBILIZATION OF EDGES AND RE-EPITHELIALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329917 AMS PERIGEE SYSTEM SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R