BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 5208454 · Received November 6, 2015

    Report

    Report Number
    2125050-2015-00104
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    April 22, 2010
    Report Date
    October 29, 2015
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    PMA / PMN Number
    K053296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. (B)(4). TOTAL NUMBER OF EVENTS SUMMARIZED - (B)(4). ARIS - (B)(4). SUPRIS - (B)(4). NOVEMBER 06, 2015: REPORT WAS DELAYED DUE TO ESG ISSUE. TICKET # (B)(4) WAS OPENED ON 10/30/2015 AND NOT RESOLVED UNTIL 11/06/2015.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH ARIS MESH ON OR ABOUT (B)(6) 2007. LATER, PATIENT WAS TREATED FOR SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE. PATIENT WAS DIAGNOSED WITH MESH EROSION. PATIENT UNDERWENT TWO SURGICAL PROCEDURES ON OR ABOUT (B)(6) 2006 AND (B)(6) 2010 TO REMOVE PORTIONS OF THE MESH AND WILL LIKELY UNDERGO ADDITIONAL CORRECTIVE PROCEDURES AND/OR ADDITIONAL MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738165 ARIS TRANS-OBTURATOR SURGICAL MESH OTN COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O