MAUDE Adverse Event Report: ESTEEM +; POUCH, COLOSTOMY

Model Number 416976

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

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Based on the available information, the event is deemed to be a reportable serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional information has been requested but has not been received to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

It was reported that a (b)(6) male end user reported a laceration with bleeding on surface of stoma.He recently tried a new pouch and states he cut the opening to the maximum diameter on the cutting surface.He wore the pouch to work.He is a doorman, which involves lifting and bending.At the end of his shift, he noticed blood in his pouch.When he removed the pouch, he saw a 1/2" laceration on the surface of the stoma with active bleeding.He went on to report that he thinks the stoma fluctuated and the opening became too tight which caused the laceration.He further reports that he changed back to his former 2 pc pouching system with a larger cutting surface.He did not seek medical attention.He reports there has been no further bleeding, and the laceration has resolved.

• Brand Name: ESTEEM +
• Type of Device: POUCH, COLOSTOMY
• MDR Report Key: 6931737
• MDR Text Key: 89037667
• Report Number: 9618003-2017-00037
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416976
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR