BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDIUM SLIP ON BRIEF

    MDR report key: 3999023 · Received August 5, 2014

    Report

    Report Number
    1033903-2014-00001
    Event Type
    Other
    Date Received
    August 5, 2014
    Report Date
    August 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    EYQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A BRIEF. THE CUSTOMER REPORTS RECEIVING A RASH FROM THE BRIEFS. THE CUSTOMER ALSO STATED SHE WENT TO A WALK-IN CLINIC AND THE DOCTOR GAVE HER AN ANTIBIOTIC, BUT THE CUSTOMER WAS UNABLE TO NAME THE MEDICATION.

    Description of Event or Problem · 1

    TWO SAMPLES WERE RECEIVED FOR FURTHER REVIEW HOWEVER NOTHING WAS OBSERVED THAT WOULD INDICATE A CAUSE FOR SKIN IRRITATION. SINCE A MANUFACTURING LOT NUMBER WAS NOT SUPPLIED BY THE CUSTOMER, IT WAS NOT POSSIBLE TO REVIEW THE DEVICE HISTORY RECORD (DHR) FOR THE PARTICULAR MANUFACTURE DAY. DUE TO THE NATURE OF THIS TYPE OF PRODUCT, IT IS MORE THAN LIKELY THAT ANY SKIN IRRITATION IS RELATED TO SKIN SENSITIVITY, AND IT IS WORTH NOTING THAT PATIENT SENSITIVITIES MAY HAVE BEEN A CONTRIBUTING FACTOR. OUR RAW MATERIALS ARE TESTED FOR BIOCOMPATIBILITY PRIOR TO USE AND THERE HAVE BEEN NO DESIGN CHANGES TO THIS PRODUCT WITHIN THE PAST YEAR THAT WOULD CONTRIBUTE TO ANY INCREASED PROBABILITY FOR SKIN IRRITATION ON PATIENTS. AT THIS TIME, A CORRECTIVE ACTION WILL NOT BE IMPLEMENTED. OUR CURRENT CONTROLS ARE SEMI-HOURLY OPERATOR INSPECTIONS OF THE FINISHED PRODUCT FOR MEETING SPECIFICATIONS AND QA MONITORING TWICE PER SHIFT. THIS COMPLAINT HAS BEEN COMMUNICATED TO ALL AFFECTED PERSONNEL. THIS COMPLAINT WILL ALSO BE USED FOR TRENDING AND TRACKING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456049 MEDIUM SLIP ON BRIEF BRIEF EYQ COVIDIEN 1605 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other