BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 3975083 · Received July 9, 2014

    Report

    Report Number
    3009325614-2014-00035
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 20, 2014
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO A CAUSALITY SEEMS POSSIBLE. NO BATCH ANALYSIS COULD BE PERFORMED SINCE INFO ABOUT THE BATCH NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED VIA A SALES REP THAT A (B)(6) MALE RECEIVED SOLESTA (DEXTRANOMER/HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE ANAL CANAL AS TREATMENT OR FECAL INCONTINENCE. ADDITIONAL MEDICAL HISTORY INCLUDED SOLESTA ON (B)(6) 2014 WITHOUT PROBLEMS. CONCURRENT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2014, THE PT RECEIVED SOLESTA. ON (B)(6) 2014, THE PT EXPERIENCED PAIN IN THE RECTAL AREA AND WAS ADVISED BY HIS PHYSICIAN TO BEGIN TUB SOAKS. THE PAIN CONTINUED TO PROGRESS OVER THE WEEKEND AND ON (B)(6) 2014, HE WAS EVALUATED IN THE PHYSICIAN'S OFFICE. THE PT WAS DIAGNOSED WITH A HEMATOMA AND A POSSIBLE ABSCESS. THE HEMATOMA WAS EVACUATED AND 8-10CC OF CLOT WERE OBTAINED. THE AREA WAS INCISED AND LEFT OPEN TO DRAIN WITH A STERILE DRESSING APPLIED. IN ADDITION, A CULTURE WAS PERFORMED WHICH SHOWED LIGHT ESCHERICHIA COLI GROWTH. THE PT WAS BEGUN ON CIPROFLOXACIN AND METRONIDAZOLE. INSTRUCTIONS INCLUDED CONTINUED TUB SOAKS AND HE WAS PRESCRIBED ACETAMINOPHEN/HYDROCODONE FOR THE PAIN. THE REPORTING NURSE AT THE PHYSICIAN'S OFFICE FELT THE EVENTS WERE SERIOUS AS THEY NECESSITATED MEDICAL/SURGICAL INTERVENTION AND THAT THE EVENTS WERE POSSIBLY RELATED TO SOLESTA. SHE WENT ON TO EXPLAIN THAT IT COULD HAVE BEEN A COINCIDENCE THAT THE PT DEVELOPED AN ABSCESS AS HE DID NOT EXPERIENCE PROBLEMS WITH THE PRIOR SOLESTA IMPLANT. IT WAS POSSIBLE THAT THE ABSCESS HAD BEEN DRAWING AND MAY HAVE FLARED UP AFTER THE INJECTION; HOWEVER, SOLESTA COULD NOT BE RULED OUT AS THE CAUSE OF THE EVENTS. THE COMPANY ASSESSED THE EVENTS AS POSSIBLY RELATED TO SOLESTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400721 SOLESTA AGENT, BULKING INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention