BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS KIT

    MDR report key: 4093847 · Received September 16, 2014

    Report

    Report Number
    2125050-2014-00397
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. THE REPORT ID NOT PROVIDE ANY INFORMATION AS TO SYMPTOMS OR IMPLANT DATE. NO EXPLANT PROCEDURE OR SUBSEQUENT TREATMENTS AND/OR THERAPIES WERE REPORTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH COLOPLAST ALTIS MESH. LATER THE PATIENT EXPERIENCED SOME PROBLEMS AND THE PHYSICIAN IS CONTEMPLATING SLING REMOVAL. NO EXPLANT PROCEDURE WAS REPORTED. NO SUBSEQUENT TREATMENTS AND/OR THERAPIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571569 ALTIS KIT SURGICAL MESH PAH COLOPLAST A/S 5196711400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other