BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 11811465 · Received May 12, 2021

    Report

    Report Number
    2125050-2021-00499
    Event Type
    Injury
    Date Received
    May 12, 2021
    Report Date
    July 24, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. 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 REVIEW DETERMINED H6 CODES A040503 "MATERIAL EROSION" AND E2403 "NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS" WERE APPLIED IN ERROR.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVESTIGATED TO THE EXTENT INFORMATION WAS PROVIDED TO COLOPLAST. DUE TO THE LEGAL NATURE OF THIS COMPLAINT AND THE DEVICE NOT BEING RETURNED FOR EVALUATION A THOROUGH INVESTIGATION COULD NOT BE EXECUTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE RE-EVALUATED AND UPDATED ACCORDING TO CURRENT PROCEDURES. COMPLAINTS OF THIS NATURE ARE MONITORED AND CAPTURED WITHIN THE PRODUCT RISK DOCUMENTATION. NO FURTHER ACTION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND DEBILITATING PAIN, DYSPAREUNIA, URINARY INCONTINENCE, URINARY TRACT INFECTION, AND MESH EROSION.

    Description of Event or Problem · 0

    ADD'L INFO REC'D 6/8/2021, AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PLAINTIFF EXPERIENCED SEVERE AND DEBILITATING PAIN, DYSPAREUNIA, URINARY INCONTINENCE, URINARY TRACT INFECTIONS, MESH EROSION. MESH REMOVED ON (B)(6) 2020.

    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, THE PATIENT WITH THIS PRODUCT EXPERIENCED MESH EROSION THROUGH THE VAGINAL EPITHELIUM AND REQUIRED EXCISION OF THE MESH WITH LMA. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711315 ALTIS SINGLE INCISION SLING SYSTEM SURGICAL MESH PAH COLOPLAST A/S 5196502400

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R