BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 5945386 · Received September 13, 2016

    Report

    Report Number
    3005706359-2016-00001
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    May 23, 2016
    Report Date
    June 14, 2016
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    PMA / PMN Number
    K080779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS NOT FILED WITHIN THIRTY (30) DAYS OF BECOMING AWARE OF INFORMATION INCLUDED HEREIN DUE TO DELAYS IN THE EMDR REGISTRATION PROCESS. THIS REPORT WAS SUBMITTED AS SOON AS EMDR REGISTRATION WAS COMPLETE.

    Additional Manufacturer Narrative · 1

    IRRIMAX IS SUBMITTING THIS FOLLOW-UP REPORT IN ACCORDANCE WITH 21 CFR § 803. THIS REPORT IS BASED ON INFORMATION PROVIDED TO IRRIMAX, WHICH IRRIMAX HAS NOT BEEN ABLE TO CONFIRM PRIOR TO THE DATE THIS FOLLOW-UP REPORT WAS SUBMITTED AND WILL NOT BE ABLE TO CONFIRM WITHOUT FURTHER ASSISTANCE FROM REPORTING PHYSICIAN.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 5 AND WAS DIAGNOSED WITH A HEMATOMA. IT WAS REPORTED THAT KEFLEX WAS USED TO TREAT THE HEMATOMA. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT ALSO HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-00002).

    Description of Event or Problem · 1

    SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 5 AND WAS DIAGNOSED WITH A HEMATOMA. IT WAS REPORTED THAT KEFLEX WAS USED TO TREAT THE HEMATOMA. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT ALSO HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-0002). IN ADDITION, ON MAY 20, 2016, THE HOSPITAL WHERE THE EVENT REPORTEDLY OCCURRED WAS INSPECTED BY THE JOINT COMMISSION, WHICH, AS A RESULT OF THE INSPECTION, TEMPORARILY DENIED FULL ACCREDITATION AFTER THE HOSPITAL FAILED TO MEET MULTIPLE STANDARDS, INCLUDING THE FOLLOWING - "[T]HE HOSPITAL HAS AN INFECTION PREVENTION AND CONTROL PLAN" AND "[T]HE HOSPITAL REDUCES THE RISK OF INFECTIONS ASSOCIATED WITH MEDICAL EQUIPMENT, DEVICES AND SUPPLIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598235 IRRISEPT WOUND CLEANSER FQH IRRIMAX CORPORATION 403 5P014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention