MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM+ FLEX CONVEX

Model Number 421623

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

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Common device name: pouch, colostomy.Based on the available information, this event is deemed to be a reportable malfunction.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the product cuts into the underside of stoma, especially when she sits causing a small amount of bleeding which pools around the bottom of stoma."bleeding resolves on its own without intervention." it was also reported that the end user's surgeon looked at it two - three months ago and end-user thinks surgeon could see a cut in the stoma, however surgeon was not concerned.Surgeon did not recommend any interventions.End-user reports that she cuts the wafer stoma opening with scissors by using the tip of the scissors and this makes a jagged edge which she tries to smooth with an emery board.No photos were provided.

• Brand Name: ESTEEM+ FLEX CONVEX
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 7916057
• MDR Text Key: 121988340
• Report Number: 1049092-2018-00476
• 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: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421623
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79