BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR SLING

    MDR report key: 9287632 · Received November 6, 2019

    Report

    Report Number
    2125050-2019-00938
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    January 15, 2015
    Report Date
    November 6, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    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: 4063335, 4063338, 4063339, 4031360, 4031361. 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 (B)(6), NUMBNESS OF THE LEGS AND FEET, WHILE RAISING HER LEG AND HER RIGHT FOOT IS NUMB, THUS FRACTURED THE CUBOID RIGHT, BEGINNING GENERALIZED PAINS IN ENTIRE BODY, INSOMNIA, DIOGNOSTIQUE OF FIBROMYALGIE. CHRONIC PAIN IN THE HIP, PELVIS, RIGHT GROIN. PAIN DIFFUSE IN THE KNEES AND IN THE SHOULDERS. BLOCKING THE LEG AND PELVIS RIGHT WHEN GETTING UP. CONSTANT HEAVINESS AND PAIN IN PELVIS, ELDERS AND RIGHT BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079524 ARIS TRANS-OBTURATOR SLING SURGICAL MESH OTN COLOPLAST A/S 5195102400 AN100115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other