SENSURA MIO OSTOMY POUCH
Received Feb 10, 2021 · Event occurred Jan 11, 2021
Report 3003814961-2021-00001 · MDR key 11307480
Device
Generic name
Mio430 1p Opw Mx Trp 10-55
Manufacturer
Coloplast A/sModel number
1048101400Lot number
7705193
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
79
- Death
- Death
Narrative
Additional Manufacturer Narrative
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
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.