BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLESTA

    MDR report key: 5106085 · Received September 25, 2015

    Report

    Report Number
    3009325614-2015-00031
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SALIX PHARMACEUTICALS, INC
    Product Code
    LNM
    PMA / PMN Number
    P100014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO B+L FOR EVALUATION; THEREFORE, PRODUCT EVALUATION COULD NOT BE CONDUCTED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW(BRR) REVIEW COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE EVENT INVESTIGATION IS UNDERWAY; A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TREATMENT WITH SOLESTA, ON HER DRIVE HOME THE PATIENT EXPERIENCED PAIN, SWELLING, FEVER AND VOMIT. THE PATIENT WAS TREATED WITH AUGMENTIN (DOSAGE AND START DATE UNKNOWN). ONE WEEK POST TREATMENT, THE PATIENT CONTINUED HAVING CRAMPS, CHILLS AND FEELS DIZZY. THE PATIENT STATED THAT SHE WAS NOT GIVEN AN ENEMA BEFORE THE PROCEDURE AND HAD A BOWEL MOVEMENT SHORTLY AFTER THE PROCEDURE. THE PATIENT DECLINED TO PROVIDE ANY OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635512 SOLESTA AGENT, BULKING, INJECTABLE LNM SALIX PHARMACEUTICALS, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other