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

Model Number 2912101800

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

Patient Problem Abdominal Pain (1685)

Event Date 01/13/2020

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

This case concerns a (b)(6) year old male who has an existing 3 year old spinal cord injury.An email was received on 1/13/2020 from the clinical nurse consultant (cnc) who reported that the patient was admitted to the hospital as he was experiencing an episode of autonomic dysreflexia, brought on by intense abdominal pain caused intussusception.The symptoms were theorised by his physician to be due to use of the peristeen system, causing him to experience reverse peristalsis leading to intussusception; therefore, causing the end user t6o suffer from autonomic dysreflexia.However, the theory is unconfirmed.The patient is seeing a colorectal surgeon and gastroenterologist to determine the relationship of the peristeen system to the patient symptoms and has undergone exploratory surgery during which 3 lots of intussusception were found.The patient has ceased used of the peristeen system until a determination can be made.No additional information was provided.

• Brand Name: PERISTEN ANAL IRRIG SYSTEM
• Type of Device: TUBES, GASTRONINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovedstaden; 3050, dnk, ; DA
• Manufacturer (Section G): COLOPLAST HUNGARY KFT; coloplast utca 2; szabolcs-szatmar-bereg; nyirbator, 4300, hun ; HU
• Manufacturer Contact: linda linsday ambroziak ; 1601 west river road n; minneapolis, mn ; 2630488
• MDR Report Key: 10112275
• MDR Text Key: 194938691
• Report Number: 3006606901-2020-00003
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2912101800
• Device Catalogue Number: 2912101800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR