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

Model Number 2914201006

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

Patient Problems Abdominal Pain (1685); Fever (1858); Peritonitis (2252); Bowel Perforation (2668)

Event Date 01/17/2022

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 from (b)(6) concerns a (b)(6)-year-old female sci patient (bmi 31) who has been irrigating with peristeen for the past 5½ years, every 2nd day, with 1000 ml and 2 pumps for inflation of the balloon.In the last 3 months prior to the event, the patient found it difficult to insert the catheters and the procedure was regularly unsuccessful.There is no information regarding the irrigation procedure which led to the bowel perforation (no information on balloon burst); at night and the day after irrigation the patient experienced abdominal pain and fever which caused hospitalisation.A ct scan diagnosed bowel perforation and peritonitis; in the subsequent laparotomy a colostomy was created.Postoperatively the patient developed pressure ulcers as she was bedridden.No more information is available.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• 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: 13710667
• MDR Text Key: 286851706
• Report Number: 3006606901-2022-00007
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2914201006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2022
• 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; Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female