MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM+; POUCH, COLOSTOMY

Model Number 416742

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Event Description

The end user reported that the filter of the pouch at 12 o'clock position had chaffed her skin due to the filter being too ridged.She recently became more hunched over and this caused some of the issue of the pouch rubbed her skin.There were no rough or sharp edges noted.There was no treatment, consumer turned the top edge down and taped it to stay down and away from her skin.The issue occurred immediately after application.She also experienced skin irritation and she continued to use the product.No photo is available at this time.

Manufacturer Narrative

Device 1 of 10.Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.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).

• Brand Name: ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15604934
• MDR Text Key: 307096989
• Report Number: 9618003-2022-05198
• 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
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 80
• Patient Sex: Female