BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 2862286 · Received November 28, 2012

    Report

    Report Number
    3009325614-2012-00019
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 2, 2012
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENTS (FEVER AND RECTAL ABSCESS) ARE KNOWN EVENTS AFTER INJECTION TREATMENT WITH SOLESTA AND ARE ALSO ADDRESSED IN THE LABELING. SWELLING OF HER PERINEUM UP TO HER LABIA IS LIKELY SECONDARY TO THE RECTAL ABSCESS.

    Description of Event or Problem · 1

    A PHYSICIAN 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 AND CONCURRENT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2012, SOLESTA WAS INJECTED. ON (B)(6) 2012, THE PT WAS HOSPITALIZED AFTER DEVELOPING FEVERS. AN ABSCESS (RECTAL) WAS DIAGNOSED AND AN INCISION AND DRAINAGE (I & D) WAS PERFORMED. THE PT CONTINUED TO EXPERIENCE FEVERS; THEREFORE, A SECOND I & D WAS PERFORMED. AGAIN, THERE WAS NO RESOLUTION OF THE FEVERS. ADDITIONAL TREATMENT HAD INCLUDED ANTIBIOTICS. ON (B)(6) 2012, THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR ONGOING TREATMENT. WHILE HOSPITALIZED, THE PT EXPERIENCED SWELLING OF HER PERINEUM UP TO HER LABIA. OUTCOME AND CAUSALITY WERE NOT REPORTED.

    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 66 YR Hospitalization