MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN ANAL IRRIGATION; RECTAL CATHETER AND ACCESSORIES; ENEMA KIT

Model Number 2912101800

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Coloplast tried to contact the patient's daughter to obtain more information but has not been successful.Coloplast contacted the outreach team which has the consumer as a client, and they have been unable to confirm that he is using or has used peristeen.To their knowledge, there has been no recent significant adverse event that can be attributed directly to peristeen.To the date of this report, there has been no additional information confirming the patient's use of peristeen, if the patient has been assessed and advised to use peristeen, the patient's death experience, and if the death was caused by peristeen.(note: the rectal catheter included in the peristeen system is a single-use component, the other components may be used multiple times).There is no additional information that provides the date when the event occured.Furthermore, there is no confirmation of product code, but the investigation suspects of code 29121.The product lot number wasn't provided and coloplast was unable to retrieve the lot and associated production documentation based on the limited information available.There have been no additional complaints registered about this item number with the same issue in may.

Event Description

Coloplast received a call from an consumer that was directed to a coloplast clinical nurse consultant in (b)(6).The end user (male) is a paraplegic who said he has used peristeen for approx 5 years.He said that his doctor said peristeen "caused him to die on the table during surgery as he had no bacteria in his gut".He then revived.He said his doctor said he died on the table due to an infection from no good bacteria in his gut.The consumer says he has been using peristeen up until a few months ago and he thinks his gp started him on it.The consumer is cognitively challenged and has been unable to provide further information despite several attempts by coloplast.The consumer has referred coloplast to his daughter for more information.

• Brand Name: PERISTEEN ANAL IRRIGATION
• Type of Device: RECTAL CATHETER AND ACCESSORIES; ENEMA KIT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY KFT; coloplast utca 2; szabolcs-szatmar-bereg, 4300 ; HU 4300
• Manufacturer Contact: mike bumgarner ; 1601 west river road n; minneapolis, MN 55411 ; 6122630488
• MDR Report Key: 8707183
• MDR Text Key: 148277919
• Report Number: 3006606901-2019-00011
• 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,foreign
• Type of Report: Initial
• Report Date: 06/17/2019

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: No Information
• Device Model Number: 2912101800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 70 YR