MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN BAG/RECTAL CATHETERS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 2912201006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Ulceration (2116); Bowel Perforation (2668)

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 of 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, the patient experienced a single area of mucosal ulceration with an extra colic abscess.It is believed to be due to repeated trauma from the irrigation catheter which resulted in perforation.The patient was hospitalized for intervention.

• Brand Name: PERISTEEN BAG/RECTAL CATHETERS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovedstaden 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY KFT; coloplast utca 2; szabolcs-szatmar-bereg; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: mike bumgarner ; 1601 west river road n; minneapolis, MN 55411 ; 6122630488
• MDR Report Key: 7580180
• MDR Text Key: 110448721
• Report Number: 3006606901-2018-00015
• 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: foreign,other
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2912201006
• Device Catalogue Number: 2912201006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR