BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 3057354 · Received April 10, 2013

    Report

    Report Number
    3009325614-2013-00019
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 21, 2012
    Report Date
    March 27, 2013
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CAUSAL RELATIONSHIP BETWEEN THE EVENTS AND THE SOLESTA TREATMENT CANNOT BE EXCLUDED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A (B)(6) FEMALE RECEIVED SOLESTA (DEXTRANOMER/HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE ANAL CANAL AS TREATMENT FOR FECAL INCONTINENCE, WEXNER SCORE 14 FOR GAS AND LOOSE STOOL. ADD'L MEDICAL HISTORY INCLUDED ALLERGIES TO TRIMETHOPRIM AND NAPROXEN. CONCURRENT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2012, THE PT RECEIVED FOUR INJECTIONS OF SOLESTA, 1 ML EACH TO 12:00, 3:00, 6:00, 9:00 O'CLOCK IN THE ANUS. ON (B)(6) 2012, THE PT WAS EXPERIENCING ANAL PAIN AND RECEIVED A PRESCRIPTION FOR ORAL DICLOFENAC. ON (B)(6) 2012, THE PT EXPERIENCED PAIN, FEVER OF 38 DEGREES CELSIUS, AND PUS FROM THE ANUS. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND A HORSESHOE ABSCESS WAS FOUND. DURING RECTAL PALPATION, LARGE AMOUNTS OF PUS WERE OBTAINED. TREATMENT INCLUDED INTRAVENOUS (IV) ANTIBIOTICS OF CEFOTAXIM AND METRONIDAZOLE. ON (B)(6) 2012, A TRANSANAL ULTRASOUND SHOWED A LARGE INTERSPHINCTERIC HORSESHOE ABSCESS. THE PT WAS TAKEN TO THE OPERATING ROOM AND THE ABSCESS DRAINED. ON (B)(6) 2012, IV ANTIBIOTICS WERE DISCONTINUED AND THE PT DISCHARGED WITH NORMAL WOUND HEALING. ON (B)(6) 2013, A F/U ULTRASOUND WAS PERFORMED WITH NO ABSCESS OBSERVED. THE PHYSICIAN FELT THE EVENTS WERE POSSIBLY RELATED TO BOTH INJECTION AND SUBSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149811 SOLESTA AGENT, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R