BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 2973647 · Received February 4, 2013

    Report

    Report Number
    3009325614-2013-00003
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    A-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A CASUAL RELATION BETWEEN THE EVENT AND THE TREATMENT CANNOT BE EXCLUDED. THE INJECTION PROCEDURE MAY HAVE CONTRIBUTED. A WARNING IS INCLUDED IN THE INSTRUCTIONS FOR USE REGARDING THE INJECTION OF THE RECTAL ANTERIOR WALL IN MEN.

    Description of Event or Problem · 1

    A NURSE REPORTED VIA A SALES REP THAT A (B)(6) MALE REC'D SOLESTA DEXTRANOMER/HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE ANAL CANAL AS TREATMENT FOR FECAL INCONTINENCE. ADD'L MEDICAL HISTORY INCLUDED DIVERTICULOSIS AND COLON POLYPS (2003). CONCURRENT MEDICATIONS WERE ESZOPICLONE AND SIMVASTATIN. ON (B)(6) 2012, THE PT REC'D 4 INJECTIONS FOR SOLESTA. ON (B)(6) 2013, THE PT WAS EVALUATED ON AN OUTPATIENT BASIS AND UNDERWENT A CYSTOSCOPY DUE TO PENILE PAIN DURING URINATION. RESULTS OF THE PROCEDURE WERE UNKNOWN. ON (B)(6) 2013, THE PT WAS ADMITTED TO A DIFFERENT HOSPITAL. HE WAS DIAGNOSED WITH A PERIPROSTATIC ABSCESS AND WAS EXPERIENCING LEUKOCYTOSIS. TREATMENT INCLUDED INTRAVENOUS ANTIBIOTICS. ON UNKNOWN DATE, THE PT WAS DISCHARGED. AT THE TIME OF THIS REPORT, HE WAS RECOVERING FROM THE EVENTS. THE PHYSICIAN FELT THE EVENT WERE POSSIBLY RELATED TO THE USE OF SOLESTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47381 SOLESTA AGENT, BULKING, IJECTABLE LNM A-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R SIMVASTATIN| LUNESTA