MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN PLUS TRANSANAL IRRIGATION WITH BALLOON CATHETERS - SYSTEM AND ACCESSOR; MANUAL RECTAL IRRIGATION SYSTEM

Catalog Number 29141 / 291410

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

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Event Description

This case concerns a 74-year-old female patient with chronic rectal prolapse and surgical rectopexy done (more than 40 years ago) and with a medical history of pancreatic exocrine insufficiency and chronic hyperkeratotic rectum due to the prolapse.On (b)(6) 2023, the patient was on holiday in spain and initiated an irrigation.The catheter was inserted, and the balloon was inflated as usual with nothing to remark on.After having irrigated with 200 ml of water the patient felt a severe instant abdominal pain and fainted immediately due to the pain.The patient has no further recollection of the incident and woke up in a hospital where she already had surgery due to the incident.A discharge letter from the hospital where the patient was admitted and had surgery described the following at diagnosis: abdominal ct scanning.Bowel perforation of about 5 cm on the lateral / posterior side of the upper rectum.Pneumoperitoneum.No generalized faecal or purulent peritonitis.The patient had surgery (high anterior resection with t-t anastomosis) and was discharged after 6 days hospital stay with improvement of the abdominal pain.No additional information required.

• Brand Name: PERISTEEN PLUS TRANSANAL IRRIGATION WITH BALLOON CATHETERS - SYSTEM AND ACCESSOR
• Type of Device: MANUAL RECTAL IRRIGATION SYSTEM
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1 humlebaek, dk 3050; DA
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17334178
• MDR Text Key: 319277821
• Report Number: 3006606901-2023-00015
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 05701780231039
• UDI-Public: 5701780231039
• Combination Product (y/n): N
• PMA/PMN Number: K083770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 29141 / 291410
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female