BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEROFRM GZE 4X3YD RL FOIL PK STRL

    MDR report key: 6064142 · Received October 28, 2016

    Report

    Report Number
    1018120-2016-00155
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 26, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 6072505 INDICATES THAT THERE WERE 0 DEFECTS DETECTED IN THE 200 SAMPLES INSPECTED FROM THE (B)(4) PRODUCT THAT WENT INTO THIS LOT. THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE REPORTED CONDITION COULD NOT BE CONFIRMED. THERE WAS NO PRODUCT MALFUNCTION OR FAILURE IN THE MANUFACTURING PROCESS. THE FOIL THAT IS INCLUDED WITHIN THE PACKAGING FOR ROLL DRESSINGS IS ONLY INTENDED TO AID IN LOCATING THE START OF THE ROLL. THE INSTRUCTIONS FOR USE (IFU) STATES "TO USE ROLL DRESSING, OPEN FOIL AS DESCRIBED ABOVE. HOLD ROLL BY HANDLE, THEN REMOVE TAPE FROM LEADING EDGE WITH STERILE FORCEPS; GRASP EDGE WITH FORCEPS AND APPLY BY UNROLLING."? THE ROOT CAUSE OF THIS INCIDENT WAS THE FAILURE TO REMOVE THE FOIL TAPE THAT IS APPLIED TO THE ROLL TO AID IN STARTING TO UNROLL THE PRODUCT. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. NO COMPLAINT TREND EXISTS AND THE INCIDENT IS NOT RELATED TO A PRODUCT OR MANUFACTURING FAILURE MODE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. AN EXISTING FORMAL INVESTIGATION ACTION IS NOT BEING TAKEN TO ADDRESS THIS FAILURE/DEFECT. A HEALTH HAZARD ANALYSIS (HHA) INITIATION FORM WAS SUBMITTED FOR THIS COMPLAINT, (B)(4). THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE. THE CUSTOMER STATES THE PATIENT WAS UNDERGOING EVACUATION OF HEMATOMA, RECONSTRUCTION OF THE VULVA, AND PACKING OF THE VAGINA. XEROFORM GAUZE ROLL WAS USED. PATIENT PRESENTED TO OUTSIDE HOSPITAL WITH VAGINAL PAIN. UPON EXAMINATION A RETAINED FOREIGN OBJECT WAS FOUND AND REMOVED. IT WAS FOUND TO BE THE SILVER FOIL TAB THAT IS USED ON THE ROLL TO GET IT STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714367 XEROFRM GZE 4X3YD RL FOIL PK STRL GAUZE FRO COVIDIEN 8884432000 6072505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other