MAUDE Adverse Event Report: COLOPLAST A/S SENSURA MIO OSTOMY POUCH; MIO430 1P OPW MX TRP 10-55

Model Number 1048101400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/11/2021

Event Type  Death  

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.

Event Description

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.

• Brand Name: SENSURA MIO OSTOMY POUCH
• Type of Device: MIO430 1P OPW MX TRP 10-55
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY KFT TAT1; búzavirág street 15; tatabánya
• Manufacturer Contact: usllam linda linsday-ambroziak ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11307480
• MDR Text Key: 231149052
• Report Number: 3003814961-2021-00001
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2022
• Device Model Number: 1048101400
• Device Lot Number: 7705193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79