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

Catalog Number	169110 / 16911
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690)
Date of Event	10/29/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3003814961-2023-00001
• Device Sequence Number: 7716611
• Product Code: EXB
• UDI-Device Identifier: 05708932893299
• UDI-Public: 05708932893299
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 169110 / 16911
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown