BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUE MALE SLING SYSTEM

    MDR report key: 10951521 · Received December 5, 2020

    Report

    Report Number
    2125050-2020-01212
    Event Type
    Injury
    Date Received
    December 5, 2020
    Report Date
    December 4, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTM
    PMA / PMN Number
    K113496
    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. 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

    ABDULLAH A, MACHKOUR F, BOUCHET E, PLAINARD X. EFFICACY OF THE VIRTUE MALE QUADRATIC SLING IN THE TREATMENT OF STRESS URINARY INCONTINENCE: A RETROSPECTIVE STUDY. PROGRÈS EN UROLOGIE (2019) 29:10; 490-495. ACCORDING TO THE AVAILABLE INFORMATION, OF 35 PATIENTS IMPLANTED, 17 PATIENTS REPORTED PAIN, TWO REPORTED PERSISTING PAIN, FOUR EXPERIENCED URGENCY, THREE EXPERIENCED ACUTE URINARY RETENTION, THREE REPORTED HEMATOMA FOLLOWING PLACEMENT, ONE REPORTED A URINARY TRACT INFECTION, AND ONE REPORTED A WOUND PROBLEM/WOUND DEHISCENCE. THE WOUND DEHISCENCE WAS MANAGED WITH SIMPLE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419379 VIRTUE MALE SLING SYSTEM SURGICAL MESH OTM COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention