BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 3763219 · Received April 7, 2014

    Report

    Report Number
    3009325614-2014-00015
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 17, 2014
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIMITED INFORMATION ABOUT THE PATIENT'S POSSIBLE UNDERLYING CONDITION MAKES A CAUSALITY ASSESSMENT DIFFICULT, HOWEVER, A CAUSALITY CANNOT BE EXCLUDED. THE INJECTION PROCEDURE PER SE AND THE FACT THAT NO PROPHYLACTIC ANTIBIOTICS WERE PROVIDED MAY HAVE CONTRIBUTED TO THE EVENTS.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED VIA A SALES REPRESENTATIVE THAT A (B)(6) MALE RECEIVED SOLESTA (DEXTRANOMER/HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE ANAL CANAL AS TREATMENT FOR "HORRIBLE" FECAL INCONTINENCE. ADDITIONAL MEDICAL HISTORY INCLUDED THAT SOLESTA WAS CONSIDERED THE "LAST RESORT" BEFORE HAVING TO PERFORM A COLOSTOMY. CONCURRENT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2014, THE PATIENT RECEIVED SOLESTA. NO ANTIBIOTICS WERE ADMINISTERED PROPHYLACTICALLY. THE PATIENT BEGAN HAVING SYMPTOMS OF AN INFECTION SOON AFTER SOLESTA INJECTION (TIMEFRAME NOT INDICATED). HE WAS DIAGNOSED WITH AN ABSCESS AND ANTIBIOTICS WERE STARTED. THE PATIENT DID NOT IMPROVE AND WAS EVALUATED BY A GASTROINTESTINAL SPECIALIST. A FLEXIBLE SIGMOIDOSCOPY WAS PERFORMED; HOWEVER, THE ABSCESS WAS NOT DRAINED. THE PATIENT WAS STILL NOT IMPROVING, SO HE WAS SEEN BY A SURGEON WHO OBSERVED THE INFECTION TO BE TRACKING INTO THE PATIENT'S PELVIS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A COLOSTOMY WAS PERFORMED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STABLE AND RECOVERING FROM THE EVENTS. CAUSALITY WAS NOT REPORTED. THE COMPANY FELT THE EVENTS WERE POSSIBLY RELATED TO SOLESTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205726 SOLESTA AGENT, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention