MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; TUBES, GASTRONINTESTINAL (AND ACCESSORIES)

Model Number 2912101004

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

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

Event Date 10/23/2020

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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.Device was not returned for evaluation.

Event Description

This case concerns an (b)(6) year-old female who previously had anal surgery (surgery type and date unknown) and reported to have used laxatives life-long.Due to faecal incontinence, tai with peristeen was initiated in (b)(6) 2020 after instructions by a coloplast home care nurse, but no information on pattern of use.As the patient had rejected the possibility of a stoma, tai with peristeen was final option for management of fecal incontinence.Between (b)(6), the patient experienced difficulties with irrigation that resulted in progressive bleeding, abdominal pain, and fever.No defects were observed on the system and catheters.The patient consulted her physician and was hospitalized.A bowel perforation located 10-12 cm above the anal sphincter was confirmed with no reports of peritonitis, and the patients was treated conservatively, ¿nutrition by infusion¿.On november 20th after 2 weeks of hospitalization the patient was discharged.The patient had lost weight, was still weak and it was recommended to continue with a light diet to support healing of the lesion.The patient and her family are not willing to provide further information.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Type of Device: TUBES, GASTRONINTESTINAL (AND ACCESSORIES)
• 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: usllam linda linsday-ambroziak ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11003400
• MDR Text Key: 221285350
• Report Number: 3006606901-2020-00016
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2912101004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 85 YR