BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE L RECT 24X8CM

    MDR report key: 8677234 · Received June 6, 2019

    Report

    Report Number
    2125050-2019-00448
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    January 10, 2017
    Report Date
    June 5, 2019
    Manufacturer
    COLOPLAST CORP
    Product Code
    OTO
    PMA / PMN Number
    K132061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, PATIENT REPORTED, "STARTED HAVING PAIN, DIFFICULT URINATING, PAINFUL SEX, HIP PAIN, LEG, BACK PAIN. DIFFICULT SITTING / STANDING LONG TERM. CAN'T DRIVE FOR LONG PERIODS OF TIME, CAN'T BICYCLE, LIMIT PHYSICAL ACTIVITIES, THEN EXPERIENCE LEAKAGE, WENT TO DOCTOR. THEY SAID NOTHING WRONG. SILL HAD SIDE EFFECTS. IN 2018 WENT TO DOCTOR ABOUT PAIN AND BLOODY DISCHARGE. HE REMOVED MESH THAT ENDED AND CAUSED DAMAGE. NERVE DAMAGE, URINARY RETENTION.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466708 RESTORELLE L RECT 24X8CM SURGICAL MESH OTO COLOPLAST CORP 5014402400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other