MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; PERISTEEN BAG/RECTAL CATHETERS

Model Number 2912101005

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

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Bowel Perforation (2668)

Event Date 02/04/2021

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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

The (b)(6) year old male was trained in using peristeen (b)(6) 2020 and has hereafter irrigated on a daily basis without problems.The event occurred on (b)(6) 2021 at the home of the end-user.The procedure was experienced to be more difficult than usual.30 minutes after completion of the irrigation the end user experienced severe pain, nausea and vomiting.He went to the (b)(6) hospital on (b)(6) and was hospitalized for a suspected bowel perforation.The diagnosis was perforation due to colic irrigation for which the treatment was conservative.No intervention was performed.He was discharged on (b)(6) 2021.No additional information was provided.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Type of Device: PERISTEEN BAG/RECTAL CATHETERS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer Contact: usllam linda linsday-ambroziak ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11529637
• MDR Text Key: 241404207
• Report Number: 3006606901-2021-00006
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K140310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2912101005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• 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 Age: 71 YR