BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSURA MIO OSTOMY POUCH

    MDR report key: 11307480 · Received February 10, 2021

    Report

    Report Number
    3003814961-2021-00001
    Event Type
    Death
    Date Received
    February 10, 2021
    Date of Event
    January 11, 2021
    Report Date
    January 27, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    A FAMILY REPRESENTATIVE/CAREGIVER ("CAREGIVER") TOLD A COLOPLAST REPRESENTATIVE THAT THE PATIENT (IDENTIFIED IN SECTION A) DIED ON (B)(6) 2021 AS A RESULT OF A COLOPLAST PRODUCT. THE CAREGIVER DID NOT IDENTIFY A DATE OF DEATH, CAUSE OF DEATH, OR NAME OF ANY PRODUCT IN USE BY THE PATIENT AT THE TIME OF DEATH. COLOPLAST'S RECORDS SHOW THAT TWO SAMPLE PRODUCTS (A SENSURA MIO OSTOMY POUCH AND BRAVA ELASTIC TAPE) WERE SENT TO THE PATIENT ON (B)(6) 2020. COLOPLAST ALSO SENT A COLOPLAST DISCHARGE KIT TO THE PATIENT ON THAT DATE. THE CAREGIVER DID NOT REPORT WHETHER THE PATIENT USED ANY OF COLOPLAST PRODUCTS SENT ON (B)(6) 2020. COLOPLAST MADE THREE TELEPHONIC EFFORTS (REACHING THE CAREGIVER EACH TIME BY TELEPHONE) AND ONE HARDCOPY EFFORT TO GAIN ADDITIONAL INFORMATION ABOUT THIS MATTER, BUT NO FURTHER INFORMATION WAS PROVIDED. COLOPLAST IS MAKING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION BUT LACKING SPECIFIC INFORMATION TO COMPLETE SOME OF THE QUESTIONS IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202936 SENSURA MIO OSTOMY POUCH MIO430 1P OPW MX TRP 10-55 EXB COLOPLAST A/S 1048101400 7705193

    Patients

    Seq Age Sex Outcome Treatment
    1 79 Death