MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN PLUS TRANSANAL IRRIGATION SYSTEM; PERISTEEN PLUS ACC. UNIT REG.

Model Number 2914201400

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

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

According to the available information, this case concerns a 23-year-old male who has been using peristeen transanal irrigation for an unknown period and for an unknown condition.The following information is available by communication with the father of the user: on (b)(6) 2023, the father inserted the peristeen plus catheter (regular size) into the anal canal of the user.The catheter was not connected to the tube and the catheter was inserted too far in the rectum and could not be retrieved.The father was advised to seek medical attention and went to the emergency unit with the son in the afternoon on the same day.The catheter was removed under anesthesia without any problems (presumable endoscopy).The user was not admitted nor prescribed any medication.It was reported that the catheter had travelled 80 cm up in the colon near the location of the spleen.No additional harms were reported.

• Brand Name: PERISTEEN PLUS TRANSANAL IRRIGATION SYSTEM
• Type of Device: PERISTEEN PLUS ACC. UNIT REG.
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16477716
• MDR Text Key: 310598815
• Report Number: 3006606901-2023-00006
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 05701780235914
• UDI-Public: 05701780235914
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2914201400
• Device Catalogue Number: 29142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2023
• 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): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male