BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L3O0100 - ACTIVE LIFE

    MDR report key: 12873567 · Received November 25, 2021

    Report

    Report Number
    9618003-2021-02717
    Event Type
    Injury
    Date Received
    November 25, 2021
    Report Date
    November 1, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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).

    Additional Manufacturer Narrative · 0

    (B)(6). 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 REPORTED THAT APPROXIMATELY 2 WEEKS AGO, HE EXPERIENCED BLEEDING FROM STOMA FROM AN AREA AT THE SKIN AND STOMA EDGE AT 9:00 FOR WHICH HE WENT TO THE HOSPITAL AND IT WAS CAUTERIZED. REPORTEDLY, HE WAS UNSURE OF THE CAUSE OR IF IT WAS RELATED TO WAFER 022758, BUT STATED IT WAS POSSIBLE. HE ALSO STATED THAT HE WAS ON BLOOD THINNER MEDICATIONS ELIQUIS AND CLOPIDOGREL. FURTHERMORE, HE HAD NO BLEEDING BUT EXPERIENCED RESULTANT DISCOMFORT NEAR SITE FROM STOOL ON HIS SKIN. HE ALSO DENIED LEAKAGE UNDER THE WAFER BUT STATED THAT STOOL DID GET ON MY SKIN AT THE EDGE OF THE WAFER. HE ALSO ADDED 839005 ALONG WITH HIS CURRENT WAFER AND IT WORKED BETTER. HIS USUAL WEAR TIME WAS 3 DAYS. EARLIER DOCUMENTED COLOSTOMY BUT TODAY STATED STOMA IS ILEOSTOMY, PRESENT SINCE 1999. PROPER SIZE AND FIT OF BARRIER OPENING WERE REVIEWED. HE PREFERRED CLIPPED CLOSURE, SENT WITH MEASURING GUIDE 400598 AND 839002. HE WAS AGREED TO CTF (CUT TO FIT) WAFER FOR TRIAL. REPORTEDLY, THE END USER CONTINUED TO USE THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    HOLD FOR CM 2/10 THE END USER REPORTED THAT APPROXIMATELY 2 WEEKS AGO, HE EXPERIENCED BLEEDING FROM STOMA FROM AN AREA AT THE SKIN AND STOMA EDGE AT 9:00 FOR WHICH HE WENT TO THE HOSPITAL AND IT WAS CAUTERIZED. REPORTEDLY, HE WAS UNSURE OF THE CAUSE OR IF IT WAS RELATED TO WAFER 022758, BUT STATED IT WAS POSSIBLE. HE ALSO STATED THAT HE WAS ON BLOOD THINNER MEDICATIONS ELIQUIS AND CLOPIDOGREL. FURTHERMORE, HE HAD NO BLEEDING BUT EXPERIENCED RESULTANT DISCOMFORT NEAR SITE FROM STOOL ON HIS SKIN. HE ALSO DENIED LEAKAGE UNDER THE WAFER BUT STATED THAT STOOL DID GET ON MY SKIN AT THE EDGE OF THE WAFER. HE ALSO ADDED 839005 ALONG WITH HIS CURRENT WAFER AND IT WORKED BETTER. HIS USUAL WEAR TIME WAS 3 DAYS. EARLIER DOCUMENTED COLOSTOMY BUT TODAY STATED STOMA IS ILEOSTOMY, PRESENT SINCE 1999. PROPER SIZE AND FIT OF BARRIER OPENING WERE REVIEWED. HE PREFERRED CLIPPED CLOSURE, SENT WITH MEASURING GUIDE 400598 AND 839002. HE WAS AGREED TO CTF (CUT TO FIT) WAFER FOR TRIAL. REPORTEDLY, THE END USER CONTINUED TO USE THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770948 L3O0100 - ACTIVE LIFE POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 022758

    Patients

    Seq Age Sex Outcome Treatment
    1 81 Male