MAUDE Adverse Event Report: COLOPLAST A/S SENSURA MIO CONVEX CLICK OSTOMY BASEPLATE; INTESTINAL OSTOMY BASE PLATE, CONVEX

Catalog Number 169110 / 16911

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Abscess (1690)

Event Date 10/29/2023

Event Type  Injury  

Event Description

According to the available information, a user of unknown age, used the sensura mio light convex click 2 pc bag and baseplate where the plastic edge of the ring on the plate got embedded in the stoma causing immense pain.The user suffered from pain the next day as well and was unable to work.On the third day, the user noticed a leakage of pus between stoma and skin prompting them to seek medical intervention at the hospital.A ct-scan revealed an inflammatory condition and abscess where the plate had penetrated the skin.The user was discharged the following afternoon and antibiotics prescribed for 7 days.The user has since advised that he is feeling better and is back at work.No further information is available at this time.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

According to the available information, a user of unknown age, used the sensura mio light convex click 2 pc bag and baseplate where the plastic edge of the ring on the plate got embedded in the stoma causing immense pain.The user suffered from pain the next day as well and was unable to work.On the third day, the user noticed a leakage of pus between stoma and skin prompting them to seek medical intervention at the hospital.A ct-scan revealed an inflammatory condition and abscess where the plate had penetrated the skin.The user was discharged the following afternoon and antibiotics prescribed for 7 days.The user has since advised that he is feeling better and is back at work.No further information is available at this time.14-dec-2023 - according to new information, the patient of this adverse event sent a discharge letter to coloplast stating that they spent less than 24 hours in the emergency department (approx.22h).Due to this new information (no prolonged hospitalization) the case is not reportable anymore.

• Brand Name: SENSURA MIO CONVEX CLICK OSTOMY BASEPLATE
• Type of Device: INTESTINAL OSTOMY BASE PLATE, CONVEX
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18184389
• MDR Text Key: 328696961
• Report Number: 3003814961-2023-00001
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 05708932893299
• UDI-Public: 05708932893299
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 169110 / 16911
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization