BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR SLING

    MDR report key: 9288365 · Received November 6, 2019

    Report

    Report Number
    2125050-2019-00977
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    June 8, 2017
    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

    THE CONTRACT MANUFACTURER REVIEWED THE DHR AND STATED SPECIFICATIONS WERE MET. COLOPLAST REVIEWED ALL LOT NUMBERS WHERE THE REPORTED ABISS LOT # WAS ASSOCIATED WITH. THE ASSOCIATED COLOPLAST LOT #S ARE: 4085003, 4085004, 4085004, 4063340, 4063337, 4063339. 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. 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 (B)(6), INJURY AND BLOCKAGE IN THE GROIN WHEN WALKING AND SORE SCIATIC NERVE WHEN TOUCHED, POSITION SITS AND WALKING AND SORE BACK TO THE NECK POSITION SITS AND LYING DOWN NO LONGER SLEEP MORE THAN TWO HOURS IN A ROW, NOT MUCH MORE EXERCISE ACCORDING TO DOCTORS, MEMORY LOSS, MUSCLE ACHES TO THE TOUCH, EXHAUSTION AFTER A DAY OF WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079144 ARIS TRANS-OBTURATOR SLING SURGICAL MESH OTN COLOPLAST A/S 5195102400 AN100116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other