BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT BACKPAD, ECG ELECTRODE

    MDR report key: 2070693 · Received April 27, 2011

    Report

    Report Number
    1320894-2011-00045
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K960264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LABORATORY EXAMINATION WAS PERFORMED ON THE COMPLAINT PRODUCT, AS NO DEVICE OR PHOTOGRAPHS WERE MADE AVAILABLE. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR SKIN REACTIONS ASSOCIATED WITH THIS PRODUCT FAMILY HAS SHOWN FOUR (4) PREVIOUS COMPLAINTS. NO DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS POSSIBLE, AS THE LOT NUMBER FOR THIS PRODUCT HAS NOT BEEN MADE AVAILABLE. NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE PRODUCT. THE DFU, DIRECTIONS FOR USE, STATES, " PREPARE THE SKIN AT THE APPLICATION SITE. (SHAVE ANY EXCESSIVE HAIR.) FOR NORMAL SKIN, USE A BRISK DRY RUB. AVOID EXCESSIVE ABRASION OF THE SKIN. FOR MOIST OR OILY SKIN, CLEANSE THE APPLICATION SITE WITH ALCOHOL: FOLLOW WITH A BRISK DRY RUB WITH GAUZE OR WIPE TO DRY THE APPLICATION SITE THOROUGHLY. (SATISFACTORY ADHESION REQUIRES THE COMPLETE DRYING OF THE ALCOHOL PRIOR TO BACK PAD APPLICATION.) " THE EVENTS SURROUNDING THIS COMPLAINT ARE UNKNOWN. THE BRISK DRY RUB MAY HAVE BEEN TOO HARSH. THE DFU STATES, "SKIN IRRITATION AT THE BACKPAD SITE MAY RESULT IF THE SKIN PREPARATION PROCEDURE IS UNDULY HARSH." IT IS POSSIBLE THAT THE SKIN UNDER THE ELECTRODE PAD SITE WAS NOT PROPERLY PREPARED, OR SOLVENTS WERE PRESENT UNDER THE PAD. THE CUSTOMER MAY HAVE USED A SKIN PREP TO PREPARE THE BACKPAD SITE PRIOR TO USE WITHOUT ALLOWING FOR THE PREPPED AREA TO COMPLETELY DRY. THE DFU STATES, "DO NOT APPLY THE BACKPAD OVER SKIN AREAS THAT SHOW SIGNS OF UNDRIED ALCOHOL, ACETONE, OR OTHER SKIN PREPARATION LIQUIDS. SUCH SOLVENTS TRAPPED UNDER THE BACK PAD CAN REDUCE ADHESION AND INCREASE THE RISK OF PATIENT SKIN IRRITATION." THE DFU ALSO CAUTIONS THE END-USER THAT, "ELECTROSURGICAL PROCEDURES WHICH EMPLOY ECG MONITORING CAN RESULT IN RADIO FREQUENCY BURNS AT ONE OR MORE ELECTRODE SITES BECAUSE, IN THEIR RECOMMENDED APPLICATION, THEY ARE FREQUENTLY PLACED CLOSE TO THE ACTIVE SURGICAL SITE. ALL ECG BACK PADS ARE MORE SUSCEPTIBLE TO THIS PROBLEM THAN INDIVIDUAL ELECTRODES. THE RISK CAN BE MINIMIZED BY THE USE OF MONITORING CABLES EQUIPPED WITH RADIO FREQUENCY INDUCTORS (RF CHOKES) OR OTHER APPROPRIATE PROTECTION TO REDUCE THE RISK OF ELECTROSURGICAL CURRENT FLOW THROUGH THE ECG ELECTRODES." PRODUCT SPECIFICATION AND BIOCOMPATIBILITY DOCUMENTS WERE REFERENCED DURING THIS INVESTIGATION. IT IS NOTED THAT THE SKIN CONTACT SUBSTANCES, CONDUCTIVE ADHESIVE GEL AND THE ADHESIVE ON THE FOAM PORTION OF THE ELECTRODE, WERE TESTED AND CONSIDERED BIOCOMPATIBLE FOR ITS INTENDED USE. ELECTRODES ARE ALSO TESTED FOR CYTOTOXICITY AND SENSITIZATION THROUGH ISO TESTING; HOWEVER, THE PATIENT COULD STILL EXPERIENCE AN ALLERGIC TYPE OF REACTION TO THE ADHESIVE OR GEL SUBSTANCES UTILIZED IN THIS PRODUCT. SINCE NO PRODUCT WAS RETURNED, THE COMPLAINT INVESTIGATION REMAINS INCONCLUSIVE. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED ANY MANUFACTURING DEFECTS WITH THIS DEVICE; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. DEVICE DISCARDED BY END-USER.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT HAD A POTENTIAL REACTION TO ADHESIVE ON PAD. THREE - 4 CM LONG REACTION ON SKIN. PAD PLACED ON SHOULDER DURING C-SECTION PROCEDURE, BURNING SENSATION FELT DURING PROCEDURE. HOURS LATER THERE WAS IRRITATION AND WITHIN A DAY BLISTERS FORMED." COMMUNICATIONS WITH THE END-USER FACILITY MADE CONMED AWARE OF TREATMENT TO THE IRRITATED AREA ON (B)(6) 2011. THE PHYSICIAN PRESCRIBED SILVADENE CREAM TO BE APPLIED TO THE SKIN IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BACKPAD, ECG ELECTRODE ADULT BACKPAD, ECG ELECTRODE DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention