BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 6138395 · Received December 1, 2016

    Report

    Report Number
    1034876-2016-00015
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    CARWILD CORPORATION
    Product Code
    NAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CALL/(B)(4) WAS RECEIVED INDICATING FINISHED GOOD (B)(4) POLYDERM FOAM DRESSING (LOT 42858726) TEARS APART EASILY AND DISINTEGRATES. THE WORK ORDER FOR THIS LOT OF FINISHED GOOD (B)(4) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE SUPPLIER OF THIS FOAM PROVIDES A CERTIFICATE OF CONFORMANCE (COC) FOR EACH LOT OF FOAM RAW MATERIAL (PART NUMBER 1127152). THE COC FOR THE LOT NUMBER LISTED IN THE WORK ORDER WAS REVIEWED. IT STATES THAT "NO CHANGES IN DESIGN, RAW MATERIAL, METHODS OF MANUFACTURING OR TESTING HAVE OCCURRED OTHER THAN AS OCCURRED IN ADVANCE IN WRITING TO THE SPECIFIED CUSTOMER." THE UNOPENED COMPLAINT SAMPLES WERE NOT RETURNED BY THE USER FACILITY. PER CONVERSATION WITH USER FACILITY REPRESENTATIVE, NONE OF THE REPORTED COMPLAINT SAMPLES TOUCHED A PATIENT. IT WAS REPORTED PRODUCT FAILURE WAS NOTICED WHEN MEDICAL PERSONNEL OPENED UP THE PACKAGES AND HANDLED THE PRODUCT. IT WAS ALSO STATED THAT THERE WAS ONE CASE OF PRODUCT INVOLVED. APPROXIMATELY 10 TO 15 INDIVIDUAL POUCHES MAY HAVE BEEN OPENED. IT WAS ALSO REPORTED THAT THE UNUSED PRODUCT WAS THROWN OUT AS SOON AS VERIFICATION OF REPLACEMENT PRODUCT WAS RECEIVED. IN MARCH 2016, THE SUPPLIER FOR THE FOAM RAW MATERIAL WAS CHANGED. THIS WAS DUE TO THE ORIGINAL VENDOR NO LONGER ABLE TO SUPPLY THIS RAW MATERIAL. PRIOR TO THIS CHANGE, RAW MATERIAL UNDERWENT THE DESIGN CONTROL PROCESS DURING WHICH IT PASSED DESIGN VERIFICATION AND VALIDATION TESTING. TESTING INCLUDED EVALUATION OF THE TENSILE STRENGTH AND FUNCTIONALITY FOR USE WITH NEGATIVE PRESSURE WOUND THERAPY. THE RAW MATERIAL PASSED ALL VERIFICATION AND VALIDATION TESTING. HOWEVER, THE TENSILE STRENGTH OF THE OLD FOAM MATERIAL WAS 1.7 TO 2.3 TIMES HIGHER THAN THAT OF THE NEW MATERIAL. AT THE TIME IT WAS CONCLUDED THAT THIS WAS STILL ACCEPTABLE AND DID NOT SIGNIFICANTLY INCREASE THE RISK OF TEARING TO SERIOUSLY IMPACT THE PATIENT. EVEN THOUGH UNUSED COMPLAINT SAMPLES WERE NOT SENT BACK, REPRESENTATIVE SAMPLES FROM SAME LOT AS THE COMPLAINT WERE FOUND AND EVALUATED. THE SAME TENSILE STRENGTH WAS PERFORMED AS THE INITIAL SAMPLES TESTED DURING MATERIAL EVALUATION. THE TENSILE STRENGTH MEAN FROM THIS ORIGINAL TESTING WAS 3.55 PSI. THE VALUE FOR THE REPRESENTATIVE SAMPLES FROM COMPLAINT LOT WAS 3.6 PSI. CALL/ COMPLAINT REPORT WAS REVIEWED FOR SALES AND SIMILAR COMPLAINT INFORMATION STARTING IN 2009. THERE HAVE BEEN A TOTAL OF 6 COMPLAINT CALLS FOR PART NUMBER 46-906, REPORTING FOAM TEARING. THE FIRST FIVE OF THESE WERE REPORTED IN JUNE AND JULY 2016, AFTER THE CHANGE OF FOAM SUPPLIER. (B)(4). BASED ON THESE RESULTS THE DESIGN TEAM FOR THIS PRODUCT WILL RE-EVALUATE THE RISK OF THE NEW FOAM MATERIAL TO IMPACT ON PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    *** QUALITY ISSUE DETAILS *** DATE OF OCCURRENCE:(B)(6) 2016. WHEN DID QUALITY ISSUE OCCUR? BEFORE USE (THERE WAS NO PATIENT INVOLVEMENT DURING REPORTED PRODUCT ISSUE). WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL WAS A MEDICAL PROCEDURE INVOLVED? NO. DETAILED DESCRIPTION OF QUALITY ISSUE: THE FOAM TEARS APART EASILY AND DISINTEGRATES. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? WOUND CARE. WAS IT THE INITIAL USE OF THE PRODUCT? YES. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY (B)(4)? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. *** OUTCOME DETAILS *** OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. WAS THE INCIDENT REPORTED TO THE FDA? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790398 DEROYAL WOUND FOAM DRESSING NAC CARWILD CORPORATION 46-906 42858726

    Patients

    Seq Age Sex Outcome Treatment
    1