MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; PERISTEEN ANAL IRRIG SYSTEM

Model Number	2912901400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Cramps (2543); Gastrointestinal Hemorrhage (4476)
Type of Reportable Event	Serious Injury
Event or Problem Description
This involves a female patient using the peristeen transanal irrigation system.The patient has been experiencing light bleeding on and off while using peristeen since early january.The patient complained of cramping and difficulty with removal of the stool.This has happened several times.The bleeding became increasingly worse until the 2nd february when she experienced heavy bleeding with a release of mucus.The patient has not used peristeen since but continued having heavy bleeding and cramping on the 11th february.On the 12th and 13th of february light bleeding was experienced and on the 14th february, light staining was noted.There has been no report of treatment for the bleeding at this time.No additional information was provided.
Additional 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.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Common Device Name: PERISTEEN ANAL IRRIG SYSTEM
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11463340
• Report Number: 3006606901-2021-00004
• Device Sequence Number: 4624921
• Product Code: KNT
• UDI-Device Identifier: 05708932544528
• UDI-Public: 05708932544528
• Combination Product (Y/N): N
• PMA/510(K) Number: K140310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 2912901400
• Device Catalogue Number: 29129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other