BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L3O0200 - NATURA

    MDR report key: 11085908 · Received December 29, 2020

    Report

    Report Number
    9618003-2020-15601
    Event Type
    Injury
    Date Received
    December 29, 2020
    Report Date
    December 7, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(6). ON (B)(6) 2021, A BATCH RECORD REVIEW WAS PERFORMED FOR LOT 0E01241. THE LOT 0E01241 WAS MANUFACTURED ON 05/16/2020 IN THE MINILINK #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MKU. BASED ON THE REVIEW CARRIED OUT, ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM. THE PROCESS WAS RUN ACCORDING TO THE APPLICABLE PROCESS INSTRUCTION. BATCH RECORD REVIEW CARRIED OUT SUPPORTS THAT NO ISSUES RELATED TO THE PROBLEM WERE IDENTIFIED. IN ADDITION, A COMPLAINT SEARCH FOR LOT 0E01241 AND MALFUNCTION CODE OST-PMC23.3 NO MALFUNCTION BASED ON COMPLAINT INFORMATION WAS CARRIED OUT AND AS A RESULT, NO ADDITIONAL COMPLAINTS WERE FOUND; THEREFORE, NO TREND FOR THIS LOT IS OBSERVED. 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

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE END USER'S STOMA WAS OVAL AND MEASURED 38 MM AT THE WIDEST, WHICH CAUSED THE 35 MM PRE-CUT WAFER STOMA OPENING TO RUB AGAINST THE STOMA. THIS CAUSED A SLIT IN THE STOMA WITH SMALL AMOUNT OF BLEEDING ON EACH SIDE OF THE STOMA AT THE WIDEST PART. IT FURTHER RESULTED IN A BLOOD BLISTER AND A SCAB. REPORTEDLY, BLEEDING RESOLVED WITHOUT INTERVENTION AND THE END USER CONTINUED TO USE THE PRODUCT. THERE WAS NO BLEEDING AT THE TIME OF THIS REPORT. HER WEAR TIME WAS 7 DAYS. THERE WAS NO ROUGHNESS OR JAGGED AREAS IN THE DEVICE. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551505 L3O0200 - NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 125274 0E01241

    Patients

    Seq Age Sex Outcome Treatment
    1