BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS SLEEVE K/L LARGE

    MDR report key: 4012124 · Received July 11, 2014

    Report

    Report Number
    1017072-2014-00006
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON AUGUST 26, 2014 INVESTIGATION WAS PERFORMED WITHOUT THE PRODUCT SAMPLE BEING RETURNED TO THE QUALITY ASSURANCE LABORATORY FOR ANALYSIS. THE LOT NUMBER INFORMATION WAS NOT PROVIDED THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED FOR PRODUCT CODE 9789 SCD EXPRESS KNEE LENGTH LARGE, HOWEVER BEFORE THE FINAL RELEASE OF A PRODUCTION LOT A REVIEW OF THE DEVICE HISTORY RECORDS FOR ANY MANUFACTURING OR QUALITY STANDARD RELATED ISSUES. WITHOUT A SAMPLE A DETAILED INVESTIGATION AND PHYSICAL TESTING OF THE PRODUCT CANNOT BE PERFORMED. A POTENTIAL ROOT CAUSE FOR THE ECHYMOSIS IS THAT A REVIEW OF THE FOR BRUISING AS A POTENTIAL HARM. IMPROPER HOOK AND LOOP POSITION ON THE SLEEVE,BLADDER VOLUME BEING TOO SMALL WERE IDENTIFIED AS POTENTIAL CAUSES. THESE RELATE TO A POSSIBLY A SLEEVE WRAPPED WITH EXCESSIVE TIGHTNESS OR WRONGLY SIZED SLEEVE RESPECTIVELY. CURRENT INSTRUCTION FOR USE (IFU'S) PROVIDE DIRECTIONS ON APPROPRIATE SIZING AND FIT OF SLEEVES AROUND A PATIENT'S LEG FOR OPTIMAL THERAPY RESULTS. BASED ON THIS INFORMATION, NO FURTHER CHANGES ARE BEING MADE IN THE MANUFACTURING PROCESS. THIS COMPLAINT WILL BE CONSIDERED CLOSED AT THIS TIME. IF ADDITIONAL INFORMATION IS OBTAINED, OR THE SAMPLE IS RETURNED, THIS FILE WILL BE RE-OPENED FOR FURTHER INVESTIGATION. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT THE CUSTOMER HAD A PATIENT THAT HAD ECCHYMOSIS WHERE THE BLADDERS ARE LOCATED ON THE SLEEVE. THE PATIENT HAD ONE LEG THAT TURNED A PURPLE DISCOLORATION FROM THE BLADDERS FROM THE SLEEVE. THE OTHER LEG HAD BANDING AND BLISTERING. THE PATIENT WAS IN INTUBATED TRAUMA PATIENT WITH INJURIES TO BOTH LEGS AND POSITION ON THEIR BACK. EVERY SHIFT-NURSE FOR THE PATIENT IS SUPPOSED TO ASSESS THE SKIN AND THE NURSE SAID THEY HAD SEEN THE PATIENT FOR A COUPLE OF DAYS BEFORE TH ISSUE STATES AND THEN A WAIT AND WATCH APPROACH BEGAN UNTIL THE DISCOLORATION WENT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408146 SCD EXPRESS SLEEVE K/L LARGE SCD SLEEVE JOW COVIDIEN 9789 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK