BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 2243396 · Received August 18, 2011

    Report

    Report Number
    1820334-2011-00442
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 22, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION - UNKNOWN AS NOT PROVIDED BY REPORTER. LESS THAN OR EQUAL TO 10 DAYS AGO. SKIN IRRITATION IS LABELED IN THE IFU. CORRECTED DATA FROM USER FACILITY REPORT. NO PRODUCT HAS BEEN RETURNED. THE PROVIDED IFU STATES THE FOLLOWING: "POSSIBLE ALLERGIC REACTIONS OR ACCESS SITE INFECTION SHOULD ALWAYS BE CONSIDERED. A STERILE INFLAMMATORY RESPONSE POSSIBLY ASSOCIATED WITH THE USE OF THE PRODUCT IN CONJUNCTION WITH LATEX AND POWDERED NON-LATEX BASED GLOVES HAVE BEEN REPORTED WITH THE USE OF THIS PRODUCT." ALTHOUGH NO CONCLUSIVE EVIDENCE EXISTS TO CONTRADICT THE STATEMENTS OF THE EVENT, THE COMPLAINT IS CONFIRMED BASED ON PRIOR SIMILAR COMPLAINTS OF STERILE INFLAMMATORY RESPONSE. WITHOUT A PATHOLOGICAL REPORT FROM THE DESCRIBED EVENT, IT IS DIFFICULT TO DETERMINE WITH CERTAINTY WHY THE FAILURE MODE OCCURRED; HOWEVER, THE SKIN IRRITATION MAY BE A RESULT OF DEVICE USE IN CONJUNCTION WITH LATEX GLOVES THAT, WITHOUT TIMELY MEDICAL INTERVENTION, MAY HAVE DEVELOPED INFECTION. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. CAPA WAS PREVIOUSLY ASSIGNED DUE TO PRIOR SIMILAR COMPLAINTS, IMPLEMENTED ON (B)(6) 2008 VIA CHANGE REQUEST, AND WAS VERIFIED EFFECTIVE ON (B)(6) 2008. THE CHANGE REQUEST REQUIRED A REDUCTION IN COATING SPEED TO REDUCE SLOUGH OFF DURING CLINICAL PROCEDURES. RISK ANALYSIS HAS BEEN PERFORMED BY QUALITY ENGINEERING ALONG WITH CORRESPONDING RISK-BENEFIT ANALYSIS AND THE RISK WAS DETERMINED TO BE ACCEPTABLE FOR THE ADDITIONAL BENEFITS OF THIS DEVICE. WITH THE ADDITION OF THIS COMPLAINT, THE RPN WILL NOT INCREASE.

    Description of Event or Problem · 1

    THE INSERTION SITE WAS PAINFUL AND SWOLLEN WITH REDNESS NOTED. THIS IS A TREND THAT THE CUSTOMER HAD NOTED AND THE PHYSICIAN HAS HAD SEVERAL WITHIN THE LAST MONTH. PATIENT OUTCOME WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other