BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS KIT

    MDR report key: 8641910 · Received May 24, 2019

    Report

    Report Number
    2125050-2019-00395
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    August 29, 2022
    Manufacturer
    COLOPLAST CORP
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODE E2402 APPLIED TO CAPTURE "SUPRAPUBIC PRESSURE". COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT IN (B)(6) 2017 THE PATIENT WAS EXPERIENCING OR HAD EXPERIENCED ALTIS MESH EXPOSURE ON THE LEFT SIDE, VAGINAL DISCHARGE, SPOTTING, SUPRAPUBIC PRESSURE, URGENCY, URGE INCONTINENCE, AND URINARY FREQUENCY. EXCISION OF VAGINAL MESH AND CYSTOURETHROSCOPY TOOK PLACE UNDER GENERAL ANESTHESIA.

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE, EMOTIONAL PAIN AND INJURY, URINARY INCONTINENCE, PHYSICAL DEFORMITY, AND THE LOSS OF ABILITY TO PERFORM SEXUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433211 ALTIS KIT SURGICAL MESH PAH COLOPLAST CORP 5196502400 4629881

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other