MAUDE Adverse Event Report: COLOPLAST A/S SENSURA MIO HIGH OUTPUT FLEX OSTOMY BAG 2-PIECE; OPEN-ENDED INTESTINAL OSTOMY BAG, MULTIPLE-PIECE

Catalog Number	18655 / 186551 / 18655 / 18655
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sepsis (2067)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, in two separate instances with products from the same box of sensura mio high output flex ostomy bag 2-piece, both the consumer and her nurse noticed mold growth on the skin.The location on the skin where the mold was noticed is not described, so it is not known whether the mold was seen in the immediate peristomal area or further away from the stoma.On the most recent occasion, the pouch was on for 3 days.When the consumer removed the pouch, both she and the nurse noticed the mold.One week later, the consumer was sent to the er with fatigue and a fever of 104ºf (40ºc).She was admitted into the hospital, had cultures taken, and the doctors uncovered she was in septic shock.The consumer stayed in the hospital for 3 weeks until she was discharged.When she was at home, she stayed on antibiotics for a short while.As of today - the consumer has fully recovered from the septic shock.No further information is available at this time.

• Brand Name: SENSURA MIO HIGH OUTPUT FLEX OSTOMY BAG 2-PIECE
• Common Device Name: OPEN-ENDED INTESTINAL OSTOMY BAG, MULTIPLE-PIECE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam; humlebæk 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 22728186
• Report Number: 3005945907-2025-00003
• Device Sequence Number: 9144036
• Product Code: EXB
• UDI-Device Identifier: 05701780003179
• UDI-Public: 05701780003179
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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: 18655 / 186551 / 18655 / 18655
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown