BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR SLING (ABISS)

    MDR report key: 24925512 · Received April 20, 2026

    Report

    Report Number
    2125050-2026-00652
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    August 6, 2025
    Report Date
    April 20, 2026
    Manufacturer
    ABISS - ANALYTIC BIOSURGICAL SOLUTIONS
    Product Code
    OTN
    UDI-DI
    03760150471231
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BECAUSE EXAMINATION OF THE RETURNED COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PAIN AND RECURRING INCONTINENCE SINCE REMOVAL OF SLING, QUALITY ACCEPTS THE OBSERVATIONS. PAIN IS A KNOWN POSSIBLE ADVERSE EVENT LABELED IN THE IFU AND/OR RISK DOCUMENTATION. AS THE SLING IS INTENDED TO BE UTILIZED FOR STRESS INCONTINENCE, THE PARTIAL REMOVAL OR FULL REMOVAL OF THE SLING MAY RESULT IN THE RETURN OF THE PATIENT'S PRE-EXISTING CONDITION OF INCONTINENCE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT. D10: PROMESH FROM COUSIN BIOTECH. PSPROLAPS2. (B)(6).

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD AN ARIS AND A COUSIN BIOTECH PROLAPSE MESH IMPLANTED. AFTER THE OPERATION, THE PATIENT HAD ABDOMINAL PAIN. THE PAIN INTENSIFIED, REMAINING PRIMARILY IN THE PATIENT'S ABDOMEN. ON DAY 6, THE PATIENT DEVELOPED PAIN IN GROIN CREASES, RADIATING DOWN THIGHS AND THEN TO FEET. AFTER THREE VISITS TO THE EMERGENCY ROOM, THE PATIENT WAS PRESCRIBED TENS AND LAROXYL (5 DROPS), BUT THESE HAD NO EFFECT. ON (B)(6) 2025, DURING AN EMERGENCY CONSULTATION WITH THE SURGEON, THE DECISION WAS MADE TO URGENTLY REMOVE THE TOT SUBURETHRAL SLING. THE SLING WAS REMOVED ON (B)(6). THE PAIN IN THE PATIENT'S THIGHS AND GROIN SUBSIDED WITHIN 48 HOURS. SOME ABDOMINAL PAIN PERSISTED, BUT THE PATIENT ATTRIBUTED THIS TO THE LAPAROSCOPY. AROUND (B)(6), APPROXIMATELY A MONTH AND A HALF AFTER THE INITIAL PROCEDURE, NEW PAINS APPEARED: LABIA, VAGINA, LOWER ABDOMEN, RATED AT 8 OUT OF 10 ON THE PAIN SCALE. THE PATIENT WAS REFERRED TO A PAIN MANAGEMENT CENTER; CURRENTLY, MEDICATION CONSISTS OF 900MG OF GABAPANTINE, 16 DROPS OF LAROXYL FOR NEUROPATHIC PAIN, NEFOPAM, AND DOLIPRANE FOR PAIN RELIEF. CURRENT PATIENT CONDITION INCLUDES DAILY PAIN: GROIN FOLDS, VAGINA, LABIA, LOWER ABDOMEN, VARYING IN INTENSITY FROM DAY TO DAY. INCREASED INCONTINENCE SINCE THE REMOVAL OF THE TOT SLING. NO RETURN TO WORK. MULTIDISCIPLINARY CARE AT THE REQUEST OF THE PAIN MANAGEMENT CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601058 ARIS TRANSOBTURATOR SLING (ABISS) FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER OTN ABISS - ANALYTIC BIOSURGICAL SOLUTIONS AX060046_UR31012022 03760150471231

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention