BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT WOUND CLEANSING SYSTEM

    MDR report key: 14455120 · Received May 20, 2022

    Report

    Report Number
    3005706359-2022-00001
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 8, 2016
    Report Date
    May 19, 2022
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    UDI-DI
    01084351100056
    PMA / PMN Number
    K080779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THE DEVICE LOT RECORDS INDICATED THE PRODUCT MET ALL SPECIFICATIONS AND REQUIREMENTS FOR RELEASE. NO FURTHER INVESTIGATION OR ASSESSMENT OF ROOT CAUSE CAN BE PERFORMED WITH THE INFORMATION AVAILABLE. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO IRRIMAX. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION TO OR CONCLUSION BY FDA, IRRIMAX, OR ITS EMPLOYEES OR AGENTS THAT THE DEVICE, IRRIMAX, OR ITS EMPLOYEES OR AGENTS CAUSED, CONTRIBUTED IN ANY WAY TO, OR ANY WAY IS CONNECTED WITH THE EVENT(S) DESCRIBED IN THIS REPORT. THE PREVIOUS PARAGRAPH SHALL BE INCLUDED IN ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC INCLUDING INFORMATION OR REPORTS PROVIDED UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE SUBJECT PRESENTED WITH ABDOMINAL PAIN, INCREASED DRAINAGE FROM A WOUND, SUPERFICIAL DEHISCENCE, AND CELLULITIS. ON (B)(6) 2016, AN EXPLORATORY LAPAROTOMY WITH REPAIR OF THE SUPERFICIAL WOUND DEHISCENCE WAS PERFORMED. NO COMPLICATIONS WERE NOTED DURING SURGERY AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2016 THE SUBJECT WAS READMITTED WITH AN INFECTION OF THE SURGICAL INCISION SITE. CULTURES TAKEN WERE POSITIVE FOR STREPTOCOCCUS TYPE B. TREATMENT CONSISTED OF IRRIGATION WITH IRRISEPT AND THE FOLLOWING MEDICATIONS: CEFDINIR, METRONIDAZOLE AND CLINDAMYCIN. THE REPORTED CONDITION RESOLVED AND THE SUBJECT WAS DISCHARGED (B)(6) 2016. THE PATIENT HAD EXPERIENCED A PRIOR ALLERGY TO CHLORHEXIDINE GLUCONATE, WHICH MAY HAVE EXACERBATED THE EXISTING TISSUE INFLAMMATION. THE EVENT WAS IDENTIFIED BY THE MANUFACTURER ON 15APR2021 DURING A RETROSPECTIVE REVIEW (CLP-01) OF A PREVIOUS CLINICAL TRIAL (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450830 IRRISEPT WOUND CLEANSING SYSTEM WOUND CLEANSER FQH IRRIMAX CORPORATION CT-901 4F052 01084351100056

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization