MAUDE Adverse Event Report: Coloplast A/S Peristeen Plus Transanal Irrigation with balloon catheters - system and accessor; Manual rectal irrigation system

Catalog Number	29142 / 29143 / 291420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bowel Perforation (2668); Gastrointestinal Hemorrhage (4476)
Date of Event	08/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This case concerns an 84-year old female patient who was enrolled in a bowel care program and had been trained on the irrigation procedure by a healthcare professional.During a follow-up contact, the patient reported that, after performing an irrigation procedure, the patient experienced bleeding and severe abdominal pain and was subsequently admitted to a hospital.According to the patient, a bowel perforation was diagnosed.While a direct causal relationship cannot be confirmed, the patient's report indicates a possible association with the irrigation procedure.The patient was unable to recall the number of pump strokes or the volume of water used during the irrigation but stated that the volume was not large.The patient reported routinely using freka glyss; however, freka glyss was not used on the day of the event, and only the irrigation procedure was performed.No additional information is currently available.

• Brand Name: Peristeen Plus Transanal Irrigation with balloon catheters - system and accessor
• Common Device Name: Manual rectal irrigation system
• Manufacturer (Section D): Coloplast A/S; 1 holtedam; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): Nyírbátor
• Manufacturer Contact: usgab giovanna hayford-quansah ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 50754244
• Report Number: 3006606901-2026-00010
• Device Sequence Number: 13060218
• Product Code: KNT
• UDI-Device Identifier: 05701780235914
• UDI-Public: 05701780235914
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 29142 / 29143 / 291420
• Device Lot Number: 10893126_2914201039
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2026
• 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: Life Threatening; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Unknown