BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 7328022 · Received March 9, 2018

    Report

    Report Number
    3002647932-2018-00003
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Report Date
    March 9, 2018
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    UDI-DI
    08717591240266
    PMA / PMN Number
    P040050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS DISCOVERED THROUGH A ROUTINE LITERATURE SEARCH. SEVERAL ATTEMPTS WERE MADE TO REACH THE AUTHOR FOR MORE INFORMATION REGARDING THE EVENT, HOWEVER NO RESPONSE WAS RECEIVED. IT WAS NOTED THAT THE PATIENT RECEIVED SEVERAL REPEAT TREATMENTS WITH MPQ DESPITE LIMITED IMPROVEMENT IN HER SYMPTOMS. THIS, COUPLED WITH THE PATIENT'S HISTORY, MAY INDICATE THAT SHE WAS A POOR CANDIDATE FOR TREATMENT.

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD CAUCASIAN FEMALE FIRST PRESENTED 20 YEARS AGO WITH BLADDER PROLAPSE AND GENUINE STRESS URINARY INCONTINENCE (SUI). AFTER FAILING TO IMPROVE ON CONSERVATIVE MANAGEMENT AND COLPOSUSPENSION, SHE UNDERWENT A MACROPLASTIQUE (MPQ) INJECTION FOR PERSISTENT URODYNAMICALLY CONFIRMED SUI. SHE EXPERIENCED BRIEF SYMPTOMATIC IMPROVEMENT, BUT SYMPTOMS REOCCURRED WITHIN MONTHS, LEADING TO THREE SEPARATE INJECTIONS OF MPQ AT SIX MONTHLY INTERVALS. EACH OF THESE INJECTIONS HAD A SIMILAR OUTCOME AS PREVIOUSLY, BUT AFTER THE FINAL INJECTION, HER SYMPTOMS PARTIALLY SETTLED, BUT SHE EXPERIENCED STORAGE SYSTEMS. SEVEN YEARS AGO, THESE STORAGE SYSTEMS WORSENED. A CYSTOSCOPY PERFORMED SHOWED MUCOSAL SWELLINGS WITH CALCIFICATIONS CLOSE TO THE BLADDER NECK AND THE PROXIMAL URETHRA. THE CALCIFICATIONS WERE RESECTED, AND HISTOPATHOLOGY SHOWED FOREIGN MATERIAL WITHOUT MALIGNANCY. THE PATIENT'S SUI DID NOT DETERIORATE ANY FURTHER, HOWEVER SHE DEVELOPED URGENCY SYMPTOMS. TWO YEARS AGO, PATIENT WAS REFERRED FOR NON-VISIBLE HAEMATURIA WITH POST-MICTURITION PAIN. A CYSTOSCOPY REVEALED UNHEALTHY AREAS CLOSE TO THE BLADDER NECK THAT WERE RESECTED. HISTOPATHOLOGY SHOWED ONLY A FOREIGN BODY REACTION, AND AN ULTRASOUND SHOWED ECHOGENIC MATERIAL IN THE BLADDER WALL CLOSE TO THE BLADDER NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172398 MACROPLASTIQUE IMPLANTS URETHERAL BULKING AGENT LNM UROPLASTY, LLC MPQ-2.5 08717591240266

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other