BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR KIT

    MDR report key: 9287624 · Received November 6, 2019

    Report

    Report Number
    2125050-2019-00941
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    January 9, 2017
    Report Date
    November 6, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    UDI-DI
    05708932442961
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST REVIEWED ALL LOT NUMBERS WHERE THE REPORTED ABISS LOT # WAS ASSOCIATED WITH. THE ASSOCIATED COLOPLAST LOT #S ARE: 5270480, 5270481, 5270482, 5241768, 5230641, 5241769. HOWEVER, BASED ON THE LIMITED INFORMATION RECEIVED, COLOPLAST CANNOT DETERMINE WHICH LOT # MAY HAVE BEEN ASSOCIATED WITH THE REPORTED COMPLAINT, SO ALL LOT #S WERE REVIEWED. THE REVIEW OF THE COLOPLAST LOT #S LISTED REVEALED NO TREND IN THE COMPLAINT, NONCONFORMING REPORT AND CAPA DATA. THE CONTRACT MANUFACTURER REVIEWED THE DHR AND STATED SPECIFICATIONS WERE MET. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION PROVIDED BY HEALTH CANADA, REPETITIVE URINARY INFECTIONS, BURNS WITHOUT BLADDER INFECTION, UPSET BELLY, LEG ACHE WITH FATIGUE AND REDUCED STRENGTH, PAIN IN SEXUAL RELATIONS, DIFFICULTY URINATING, DISCOMFORT, MILD PAIN TO URINATE, TIRED, SENIOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079516 ARIS TRANS-OBTURATOR KIT SURGICAL MESH OTN COLOPLAST A/S 5195512400 AQ040023 05708932442961

    Patients

    Seq Age Sex Outcome Treatment
    1 Other