BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0200 - NATURA

    MDR report key: 12311584 · Received August 12, 2021

    Report

    Report Number
    9618003-2021-01667
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Report Date
    July 23, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD REVIEW RESULTS: LOT 1C00713 WAS MANUFACTURED ON 03/06/2021 IN THE MLK-1 MANUFACTURING LINE, WITH A TOTAL OF (B)(4). ON 22SEP/2021, A BATCH RECORD REVIEW WAS PERFORMED TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM, UNDER SAP MATERIAL 1020975 AND MANUFACTURING ORDER 1573608. THE TESTING RESULTS WERE FOUND SATISFACTORY. THEREFORE, NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. IN ADDITION, BULK LOTS 1C01033, 1B02348, 1B00765 & 1B01269, SAP MATERIAL 1014162, MANUFACTURED IN ELC4 LINE WERE REVIEWED AND NO ISSUES FOUND. ON 22/SEP/2021, A COMPLAINT SEARCH FOR LOT 1C00713 AND MALFUNCTION CODE OST-PMC01.14 SKIN BARRIER IN CONTACT WITH SKIN IS TOO ROUGH OR SHARP, SHARP EDGES AT STOMA MAY OCCUR WAS CARRIED OUT AND AS A RESULT, NO ADDITIONAL COMPLAINTS WERE FOUND; THEREFORE, NO POTENTIAL TREND IS OBSERVED AND THIS CASE IS CONSIDERED AN ISOLATED INCIDENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE END USER STATED THAT AFTER THE SECOND DAY OF USE, THE OUTER EDGES OF THE WAFER BEGAN TO TURN VERY HARD, CRUMBLY AND BRITTLE, ALMOST LIKE HARD PLASTIC. SHE STATED THAT IT BECAME VERY UNCOMFORTABLE TO WEAR THE PRODUCT AND THE EDGES BEGAN TO SCRATCH HER SKIN WHEN SHE MOVED. SHE HAD TO REMOVE THE PRODUCT AFTER TWO DAYS BECAUSE OF THE SCRATCHING OF THE WAFER AGAINST HER ABDOMINAL SKIN CAUSING SKIN EXCORIATION. THE END USER GENTLY CLEANSED AND DRIED THE SKIN AND CHANGED THE BARRIER. SHE USED A VERY SOFT NON-COMPANY PRODUCT, WHICH LEFT MOST OF THE SCRATCHED SKIN UNCOVERED AND ALLOWED IT TO HEAL. THE SKIN WAS BACK TO NORMAL. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210624 L3O0200 - NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 401575 1C00713

    Patients

    Seq Age Sex Outcome Treatment
    1