BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 3065627 · Received April 15, 2013

    Report

    Report Number
    3009325614-2013-00017
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RELATION TO THE TREATMENT CANNOT BE TOTALLY EXCLUDED; HOWEVER, THE INJECTION TECHNIQUE OR THE INJECTION PROCEDURE PER SE MAY HAVE CONTRIBUTED TO THE EVENT. THE REPORTED EVENTS ARE ADDRESSED IN THE LABELING. DEVICE FAILURE/OUT OF SPECIFICATION CONDITION IS NOT SUSPECTED.

    Description of Event or Problem · 1

    A NURSE PRACTITIONER REPORTED VIA A SALES REP THAT A (B)(6) 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 DIABETES, HYPERTENSION, COLON CANCER, CHRONIC BACK PAIN, HYPOTHYROIDISM, AND ASTHMA. CONCURRENT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2013, THE PT REC'D FOUR SOLESTA INJECTIONS. ON (B)(6) 2013, THE PT WAS SEEN BY HER PHYSICIAN FOR RECTAL PAIN, FEVER, AND DIFFICULTY HAVING BOWEL MOVEMENTS. UPON EXAMINATION, THE PT WAS FOUND TO BE DRAINING PURULENT PUS FROM A RECTAL ABSCESS. SHE WAS HOSPITALIZED AND UNDERWENT AN INCISION AND DRAINAGE (I&D) OF THE ABSCESS. THE PT WAS GIVEN INTRAVENOUS PIPERACILLIN/TAZOBACTAM WHILE HOSPITALIZED. ON (B)(6) 2013, THE PT WAS DISCHARGED ON ORAL AMOXICILLIN/CLAVULANATE TREATMENT. THE EVENTS HAVE IMPROVED, BUT ARE STILL PRESENT. THE NURSE PRACTITIONER DID NOT HAVE AN OPINION ON CAUSALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160366 SOLESTA AGENT, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R