BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR SLING (COLOPLAST)

    MDR report key: 13525521 · Received February 14, 2022

    Report

    Report Number
    2125050-2022-00131
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    October 11, 2011
    Report Date
    October 29, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    UDI-DI
    05708932442954
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE - LOT: AK060033. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED. COLOPLAST ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS INFORMATION NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT EXPERIENCED DISCOMFORT, DYSPARUNIA, EROSION, AND AN ARTIFACT WAS IDENTIFIED IN THE BODY. THE PATIENT UNDERWENT CYSTOSCOPY AND PELVIC MRI.

    Description of Event or Problem · 0

    AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT CONSULTED WITH STRESS URINARY LEAKAGE AND TRANS OBTURATOR SLING URETHROPEXY (ARIS) WAS PERFORMED IN (B)(6) 2011. THE PATIENT PRESENTED WITH POSTOPERATIVE PELVIC DISCOMFORT EVOLVING OVER SEVERAL YEARS. AN ENDOSCOPY WAS PERFORMED IN 2011, AND REDNESS WAS NOTED AT THE BLADDER NECK, WITH NO CLEAR PERFORATION OF THE SLING. IN MARCH 2019, ENDOSCOPY REVEALED RIGHT PARURETHRAL PAIN AND INTRAVESICAL STRIP EROSION AND SLING REMOVAL IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263021 ARIS TRANSOBTURATOR SLING (COLOPLAST) SURGICAL MESH OTN COLOPLAST A/S 5195512400 AK060033_5195102400 05708932442954

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention