BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA+

    MDR report key: 16049264 · Received December 27, 2022

    Report

    Report Number
    9618003-2022-05413
    Event Type
    Injury
    Date Received
    December 27, 2022
    Report Date
    December 2, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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 · 0

    THE END USER SPOKE WITH OUR COMPANY¿S TEAM SPECIALIST AND REPORTED THAT SHE HAD INFECTION ON RIGHT THIGH WHERE THE POUCH LEAKED. THEN, AFTERWARDS, AN ADDITIONAL INFORMATION WAS RECEIVED, AND SHE REPORTED THAT SHE DEVELOPED LITTLE RED BUMPS THAT WERE ITCHY ON HER MEDIAL RIGHT THIGH APPROXIMATELY TWO TO THREE MONTHS AFTER INITIALLY STARTING TO USE THE POUCH. THE END USER VERIFIED THAT SHE PROBABLY ALSO SCRATCHED THE AREA DUE TO THE ITCHY RASH AND CLARIFIED THAT SHE WORE THE POUCH VERTICALLY EXCEPT FOR SLEEPING SO THAT THE POUCH WOULD NOT CONTACT THIS AREA. SHE WAS NOT CERTAIN WHETHER OR NOT THE POUCH CONTACTED THIS AREA DURING SLEEP. SHE HAD FELT SOME MOISTURE IN THAT AREA AND THOUGHT THIS MIGHT BE THE POUCH WAS LEAKING. HOWEVER, SHE STATED THAT SHE NEVER ACTUALLY SAW MOISTURE OR EFFLUENT IN THE AFFECTED AREA. APPROXIMATELY FIVE MONTHS AFTER DEVELOPING THE RASH, SHE SAW HER PRIMARY PHYSICIAN WHO PRESCRIBED AN UNKNOWN OINTMENT AND WARM COMPRESSES WITHOUT PROVIDING ANY SPECIFIC DETAILS. THE RASH DEVELOPED A LARGE BOIL THAT WAS THE SIZE OF THE PALM OF HER HAND, AND SHE WAS HOSPITALIZED, AND INTRAVENOUS ANTIBIOTICS WERE STARTED. CULTURES CAME BACK POSITIVE FOR A STAPHYLOCOCCUS INFECTION AND FINAL CULTURES SHOWED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). FURTHER THE BOIL WAS DRAINED, AND SHE WAS HOSPITALIZED FOR APPROXIMATELY A WEEK APPROXIMATELY ONE YEAR AGO. THE RASH CLEARED BUT CAME BACK INTERMITTENTLY AND TOOK MONTHS TO CLEAR. AT THIS POINT, SHE SELF-TREATED WITH ANTIFUNGAL CREAMS AND ANTIBIOTIC CREAMS. SHE STATES IT WAS UNDER CONTROL AND NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME. SHE DID NOT RECALL OTHER DETAILS. SHE HAS NEVER BEEN TOLD TO STOP USING THE PRODUCT. EVEN WHILE HOSPITALIZED AND THE RASH CLEARED, SHE WAS USING THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449374 NATURA+ POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 416417

    Patients

    Seq Age Sex Outcome Treatment
    1 63 Female