BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 3874135 · Received May 29, 2014

    Report

    Report Number
    3009325614-2014-00033
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION, A CAUSALITY SEEMS POSSIBLE. SINCE THE PATIENT WAS HOSPITALIZED AND TREATED WITH INCISION AND DRAINAGE OF A PERIRECTAL ABSCESS THE CASE FULFILLS THE CRITERIA FOR REGULATORY REPORTING.

    Description of Event or Problem · 1

    A NURSE REPORTED VIA A SALES REPRESENTATIVE THAT A (B)(6) FEMALE RECEIVED SOLESTA (DEXTRANOMER/HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE ANAL CANAL AS TREATMENT FOR FECAL INCONTINENCE. ADDITIONAL MEDICAL HISTORY INCLUDED PRIOR SOLESTA INJECTION IN (B)(6) 2013 WITHOUT PROBLEMS. CONCURRENT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2014, THE PATIENT RECEIVED SOLESTA. ON (B)(6) 2014, THE PATIENT WAS BEING EVALUATED IN HER PHYSICIAN'S OFFICE FOR A BURNING SENSATION IN HER RECTUM AND "NOT FEELING WELL" WHICH RESULTED IN THE PATIENT HAVING "TROUBLE GETTING OUT OF BED". BASED ON THE SUBJECTIVE COMPLAINTS, THE PHYSICIAN SUSPECTED A POSSIBLE ABSCESS. THE PATIENT WAS SENT FOR A COMPUTED TOMOGRAPHY SCAN AND BLOOD WORK. SHE WAS DIAGNOSED WITH A PERIRECTAL ABSCESS AND HOSPITALIZED. AN INCISION AND DRAINAGE WAS PERFORMED. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED WITH THE DRAIN STILL IN PLACE. AS OF (B)(6) 2014, THE PATIENT WAS RECOVERING AND THE DRAIN REMAINED INTACT. CAUSALITY WAS NOT PROVIDED. THE COMPANY ASSESSED THE EVENTS AS POSSIBLY RELATED TO SOLESTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316914 SOLESTA AGENT, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention