BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 2889366 · Received December 18, 2012

    Report

    Report Number
    3009325614-2012-00027
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CASUAL RELATION BETWEEN THE EVENT AND THE TREATMENT CANNOT BE EXCLUDED. THE EVENT IS ALREADY ADDRESSED IN THE RISK MANAGEMENT REPORT/LABELING BY A WARNING REGARDING THE INJECTION PROCEDURE IN MEN WITH ENLARGED PROSTATE. NO CORRECTIVE ACTION WILL BE INITIATED.

    Description of Event or Problem · 1

    A GASTROENTEROLOGIST REPORTED THAT A (B)(6) MALE RECEIVED SOLESTA (DEXTRANOMER/ HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE ANAL CANAL AS TREATMENT FOR FECAL INCONTINENCE. ADDITIONAL MEDICAL HISTORY INCLUDED BENIGN PROSTATIC HYPERTROPHY, COLON POLYPS, CHRONIC ANAL FISSURE, CARPAL TUNNEL, DYSLIPIDEMIA, HYPERTENSION, AND INCOMPLETE BLADDER EMPTYING. CONCURRENT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2012, THE PATIENT RECEIVED SOLESTA IN HIS PHYSICIAN'S OFFICE. THREE INJECTIONS WERE ADMINISTERED. APPROXIMATELY 24-36 HOURS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH SYMPTOMS OF AN ABSCESS. HE REQUIRED HOSPITALIZATION DUE TO AN ABSCESS IN HIS PROSTATE AREA. THE PATIENT WAS EVALUATED BY A SURGEON AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. THE PATIENT WAS HOSPITALIZED FOR 3-4 DAYS BEFORE BEING DISCHARGED ON ORAL ANTIBIOTICS. HE WAS TO BE RE-IMAGED IN ONE WEEK TO EVALUATE THE STATUS OF THE ABSCESS. AS OF (B)(6) 2012, THE EVENT WAS IMPROVED, BUT STILL PRESENT. THE PHYSICIAN FELT THE EVENT WAS RELATED TO THE USE OF SOLESTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLESTA AGENT, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R