BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODES

    MDR report key: 3788418 · Received April 29, 2014

    Report

    Report Number
    1000317571-2014-00025
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    CONVATEC LIMITED
    Product Code
    GEI
    PMA / PMN Number
    K955261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY BASED ON A PRELIMINARY CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE DIATHERMY PAD AND THIS EVENT IS DEEMED POSSIBLY RELATED BECAUSE PRODUCT USE IS TEMPORALLY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED; HOWEVER, NO INFORMATION IS KNOWN REGARDING DE/RECHALLENGE. MEDICAL TREATMENT HAS BEEN DOCUMENTED ON THE WHO CHECK LIST AND AN IR1 FORM COMPLETED AS PER CASE DETAILS. AN INVESTIGATION PERFORMED ON (B)(6) 2012 BASED ON THE REVIEW OF THE FOLLOWING: RETAINS; PRODUCTION BATH RECORDS; COPY OF OPERATOR INSTRUCTION; HISTORICAL COMPLAINT DATABASE FROM 2008 TO DATE; AND PRODUCT RISK REVIEW OF THE FAMILY OF NEUTRALECT ELECTROSURGICAL PRODUCTS ((B)(4) 2011). RESULTS ARE AS FOLLOWS: REVIEW OF THE BATCH HISTORY RECORDS FOR THE SPECIFIED ELECTRODE SHOWED NO ABNORMALITIES RECORDED DURING THE MANUFACTURING PROCESS; REVIEW THE COMPLAINTS HISTORICAL DATA BASE SHOW A TOTAL OF 9 COMPLAINTS WERE RECEIVED DURING THAT TIME PERIOD WHICH COINCIDES WITH (B)(4) DIATHERMY GROUNDING PLATES BEING RELEASED FOR USE IN THE MARKETS; PRODUCT RISK REVIEW (PRR) SHOWED A LIST OF COMPLAINTS INCLUDED 7 RELEVANT CUSTOMER COMPLAINTS, AND A CLINICAL EVALUATION SUMMARY THAT CONCLUDED THAT DATA PRESENTED IN THE CLINICAL EVALUATION REPORT SUPPORTED AN ACCEPTABLE SAFETY PROFILE WHICH IS CONSISTENT WITH THE PRR. THEREFORE, THE CURRENT PRODUCT DESIGN PERFORMANCE IN THESE LOTS IS JUDGED CONSISTENT WITH DESIGN REQUIREMENTS. THE ISSUES DESCRIBED ARE JUDGED TO BE RARE AND INFREQUENT IN THE USE OF THESE PRODUCTS. (B)(4) GROUNDING PLATES HAVE BEEN RELEASED TO THE MARKET PLACE SINCE (B)(4) 2008. THIS LATEST COMPLAINT FREQUENCY IS CONSISTENT WITH THE PREVIOUS, ACCEPTABLE LOW INCIDENCE. THESE SPECIFIC OBSERVATIONS MAY HAVE ARISEN FROM PARTICULAR SKIN SENSITIVITIES IN THESE INDIVIDUAL PATIENTS. THERE IS NO SYSTEMATIC ISSUE WITH THESE SPECIFIED LOTS. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM (B)(4),2011 - (B)(4) 2013. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILST REMOVING THE DIATHERMY ELECTRODE SOME OF THE PATIENTS SKIN CAME AWAY ON THE PAD RESULTING IN SKIN DAMAGE (SUPERFICIAL LAYER OF SUBCUTANEOUS TISSUE) TO DIATHERMY SITE LEFT LEG OF PATIENT. REPORTS STATES THAT PATIENT WAS INFORMED AND DRESSING WAS APPLIED TO THE AFFECTED SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255740 ELECTRODES ELECTROSURGICAL, CUTTING & COAGULATING GEI CONVATEC LIMITED 2506M 716227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention