BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN MARKER

    MDR report key: 8116867 · Received November 29, 2018

    Report

    Report Number
    1060680-2018-00009
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 1, 2018
    Report Date
    February 5, 2019
    Manufacturer
    PRIVATE LABEL PRODUCTS, INC.
    Product Code
    FZZ
    UDI-DI
    50749756157488
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE SKIN MARKER IS SUPPLIED TO DEROYAL BY PRIVATE LABEL PRODUCTS. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO PRIVATE LABEL PRODUCTS. IN ITS RESPONSE, THE MANUFACTURER STATED THAT THE ROOT CAUSE IS UNDETERMINED. THE SAMPLE WAS RECEIVED AND INSPECTED AND FOUND TO BE WORKING AS INTENDED. INDEPENDENTLY, DEROYAL HAS PERFORMED BIOCOMPATIBILITY TESTING, INCLUDING SKIN IRRITATION AND SENSITIZATION, ON THIS PRODUCT AND MET THE REQUIREMENTS OF THE ISO 10993-10 STANDARD. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, PRIVATE LABEL PRODUCTS STATED THAT, DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A PATIENT HAD AN ALLERGIC REACTION FOLLOWING THE USE OF A SKIN MARKER (PART 26-002, LOT 45438161) IN A SURGERY. A SAMPLE WAS INITIALLY REPORTED TO BE AVAILABLE FOR RETURN. THE SAMPLE WAS RETURNED AND FORWARDED TO THE MANUFACTURER FOR EVALUATION. THIS PRODUCT HAS UNDERGONE PRIMARY SKIN IRRITATION AND BUEHLER SENSITIZATION TESTING IN ITS FINAL, FINISHED FORM. THE RESULTS FOR BOTH TESTS MET THE REQUIREMENTS OF THE STANDARD. THE DEROYAL COMPLAINT INVESTIGATOR REVIEWED THE BIOBURDEN RESULTS FOR AN EQUIVALENT SKIN MARKER PART (THE MARKERS CONTAIN THE SAME INK) IN THE MOST RECENT CHAMBER VALIDATION AND ALL RESULTS WERE FOUND TO BE WITHIN THE ACCEPTABLE RANGE. THE WORK ORDER FOR THE REPORTED LOT WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. ONE DEFECT FOR A DIRTY PRODUCT WAS FOUND AND DOCUMENTED. THE SKIN MARKER IS SUPPLIED TO DEROYAL BY PRIVATE LABEL PRODUCTS. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED NOVEMBER 2, 2018, TO PRIVATE LABEL PRODUCTS. A RESPONSE WAS RECEIVED AND ACCEPTED JANUARY 11, 2019, BY DEROYAL PERSONNEL. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2016 TO 2018. EACH CASE CONTAINS 50 EACH, WHICH EQUATES TO A TOTAL OF (B)(4) EACHES SOLD. INTERNAL COMPLAINTS WERE REVIEWED FOR THE SAME TIME PERIOD. NO COMPLAINTS WERE IDENTIFIED FOR THE SAME ISSUE THAT WAS REPORTED IN THIS INCIDENT. THIS RESULTS IN A SALES-TO-COMPLAINT RATIO OF (B)(4). THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    AN END USER REPORTED AN INCIDENT OF ALLERGIC REACTION RIGHT AFTER SURGERY. A TYPE 1 RESPONSE AND TYPE 4 RESPONSE WERE REPORTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A PATIENT HAD AN ALLERGIC REACTION FOLLOWING THE USE OF A SKIN MARKER (PART 26-002, LOT 45438161) IN A SURGERY. A SAMPLE WAS INITIALLY REPORTED TO BE AVAILABLE FOR RETURN. HOWEVER, AS OF THE DATE OF THIS REPORT, A SAMPLE HAS NOT BEEN RETURNED. THIS PRODUCT HAS UNDERGONE PRIMARY SKIN IRRITATION AND BUEHLER SENSITIZATION TESTING IN ITS FINAL, FINISHED FORM. THE RESULTS FOR BOTH TESTS MET THE REQUIREMENTS OF THE STANDARD. THE WORK ORDER FOR THE REPORTED LOT WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. ONE DEFECT FOR A DIRTY PRODUCT WAS FOUND AND DOCUMENTED. THE SKIN MARKER IS SUPPLIED TO DEROYAL BY PRIVATE LABEL PRODUCTS. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED NOVEMBER 2, 2018, TO PRIVATE LABEL PRODUCTS. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2016 TO 2018. EACH CASE CONTAINS 50 EACH, WHICH EQUATES TO A TOTAL OF (B)(4) "EACHES" SOLD. INTERNAL COMPLAINTS WERE REVIEWED FOR THE SAME TIME PERIOD. NO COMPLAINTS WERE IDENTIFIED FOR THE SAME ISSUE THAT WAS REPORTED IN THIS INCIDENT. THIS RESULTS IN A SALES-TO-COMPLAINT RATIO OF (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    AN END USER REPORTED AN INCIDENT OF ALLERGIC REACTION RIGHT AFTER SURGERY. A TYPE 1 RESPONSE AND TYPE 4 RESPONSE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957521 SKIN MARKER MARKER, SKIN FZZ PRIVATE LABEL PRODUCTS, INC. 26-002 45438161 50749756157488

    Patients

    Seq Age Sex Outcome Treatment
    1