BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR KIT

    MDR report key: 12230438 · Received July 27, 2021

    Report

    Report Number
    2125050-2021-00982
    Event Type
    Injury
    Date Received
    July 27, 2021
    Report Date
    July 27, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    UDI-DI
    05708932442961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # AK090053. CORRECTIVE ACTION: MANAGEMENT ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE RELATING TO THE REPORTED COMPLAINTS ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS, AND BECAUSE THE DEVICE IS NOT AVAILABLE FOR EVALUATION, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ACCORDING TO THE AVAILABLE INFORMATION, ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT¿S LEGAL REPRESENTATIVE STATED URGE AND STRESS INCONTINENCE AND PELVIC PAIN. ARIS TRANS OB WAS IMPLANTED ON (B)(6) 2011 AND REMAINS IMPLANTED. ON (B)(6) 2011- BLOOD IN URINE. ON (B)(6) 2011- BLEEDING, UI AT NIGHT AND OCCASIONALLY DURING THE DAY. ON (B)(6) 2013- PELVIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128048 ARIS TRANSOBTURATOR KIT SURGICAL MESH OTN COLOPLAST A/S 5195101000 05708932442961

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR