BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPRIS SUPRAPUBIC KIT

    MDR report key: 2821009 · Received November 6, 2012

    Report

    Report Number
    2125050-2012-00103
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 6, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    PMA / PMN Number
    K111233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT. (B)(4): DEVCIE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH MESH (B)(6) 2011 AND LATER EXPERIENCED PAIN DURING SEXUAL INTERCOURSE, SHE COULD FEEL THE MESH ALONG WITH HUSBAND AS WELL AS COMPLICATIONS WITH BLADDER AND KIDNEY INFECTIONS. MESH WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPRIS SUPRAPUBIC KIT PUBORUETHRAL SUPPORT TAPE OTN COLOPLAST A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other