BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 3590755 · Received January 15, 2014

    Report

    Report Number
    3009325614-2014-00001
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    November 22, 2013
    Report Date
    December 23, 2013
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT SEEMS POSSIBLE. THE INJECTION TECHNIQUE OR THE INJECTION PER SE MAY ALSO HAVE CONTRIBUTED TO THE EVENT. THE REPORTED EVENTS ARE ADDRESSED IN THE LABEL. LOT NUMBER WAS NOT REPORTED AND TRENDING ON BATCH CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    A (B)(6) YR OLD FEMALE REC'D SOLESTA (DEXTRANOMER/HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE ANAL CANAL AS TREATMENT FOR FECAL INCONTINENCE. ADD'L MEDICAL HISTORY INCLUDED AORTIC REGURGITATION, FIBROMYALGIA, AND INTERSTIM ((B)(6) 2013). CONCURRENT MEDICATIONS WERE DULOXETINE, GABAPENTIN, AND MULTIVITAMINS. ON (B)(6) 2013, THE PT REC'D SOLESTA. SHE IMMEDIATELY EXPERIENCED ABDOMINAL BLOATING AND A RECTAL ABSCESS ON (B)(6) 2013, THE PT UNDERWENT SURGERY TO REPAIR THE RECTAL ABSCESS. THE PT HAS CONTINUED TO EXPERIENCE SEVERE PAIN FROM THE RECTAL ABSCESS. ON A PAIN SCALE OF 1-10, HER PAIN WAS REPORTED AS AN 8 OR 9. SHE HAS BEEN TAKING OXYCODONE WITH NO IMPROVEMENT. THE OUTCOME WAS UNCHANGED AT THE TIME OF THIS REPORT. THE COMPANY FELT THE EVENTS WERE POSSIBLY RELATED TO SOLESTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39685 SOLESTA AGEN, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention GABAPENTIN| MULTIVITAMINS| CYMBALTA