MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN ANAL IRRIG SYSTEM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 2912101001

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

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, a (b)(6)-year-old female patient with a medical history of rectal cancer and low rectal resection 18 months ago.November 21st: due to fecal incontinence trans anal irrigation was initiated.The training was done by a represent from the home delivery company, in presence of a community nurse.First irrigation went well.Regular follow-up visits took place every 3 days/week by a community nurse.November 29th: the patient experienced difficulties to instill the water.December 1st : the patient experienced an acute abdominal pain and the sensation of a "crack" inside her when performing the irrigation procedure at home.Suspicion of perforation.Following the occurrence of peritonitis the patient underwent surgery with formation of a colostomy.

• Brand Name: PERISTEEN ANAL IRRIG SYSTEM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY KFT; coloplast utca 2; szabolcs-szatmar-bereg; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: mike bumgarner ; 1601 west river road n; minneapolis, MN 55411 ; 6122630488
• MDR Report Key: 9508862
• MDR Text Key: 182180207
• Report Number: 3006606901-2019-00020
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2912101001
• Device Catalogue Number: 2912101001
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR