BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 4553855 · Received February 25, 2015

    Report

    Report Number
    3009325614-2015-00011
    Event Type
    Injury
    Date Received
    February 25, 2015
    Date of Event
    January 12, 2015
    Report Date
    February 6, 2015
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT CANNOT BE EXCLUDED. ALTHOUGH WE DO NOT UNDERSTAND WHY THE PATIENT DEVELOPED URINARY RETENTION. DID THE PATIENT HAVE A PREDISPOSITION, E.G. PROSTATIC HYPERTROPHY? LOT NUMBER HAS NOT BEEN REPORTED AND TRENDING ON BATCH CANNOT BE PERFORMED. THE CASE HAS BEEN ASSESSED AS SERIOUS AND FULFILLS CRITERIA FOR REPORTING.

    Description of Event or Problem · 1

    A MEDICAL ASSISTANT REPORTED THAT A (B)(6) YEAR OLD MALE 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) 2015, THE PATIENT RECEIVED SOLESTA. PROPHYLACTIC ANTIBIOTICS WERE NOT ADMINISTERED PRIOR TO IMPLANTATION. ON THAT SAME DATE, THE PATIENT EXPERIENCED A FEVER AND "NOT URINATING AS WELL". THE PATIENT WAS EVALUATED BY HIS PHYSICIAN ON (B)(6) 2014 AND TREATMENT BEGAN WITH ACETAMINOPHEN/OXYCODONE AND AMOXICILLIN CLAVULANATE. THE PATIENT WAS AGAIN SEEN BY HIS PHYSICIAN ON (B)(6) 2015 WITH COMPLAINTS OF RECTAL DISCOMFORT. ON (B)(6) 2015, THE PATIENT WAS HOSPITALIZED FOR CELLULITIS IN THE RECTAL AND URINARY RETENTION. WHILE HOSPITALIZED, THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS AND A FOLEY CATHETER WAS INSERTED TO TREAT THE URINARY RETENTION. ON (B)(6) 2015, THE PATIENT WAS DISCHARGED. THE EVENTS WERE CONSIDERED COMPLETELY RESOLVED ON AN UNSPECIFIED DATE. THE REPORTER FELT THE EVENTS WERE POSSIBLY RELATED TO THE USE OF SOLESTA. THE COMPANY ASSESSED THE EVENTS AS POSSIBLY RELATED TO SOLESTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133257 SOLESTA AGENT, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R