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

Model Number 421622

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Distress (2329); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

A2: age at the time of event - 74 years.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.Third party manufacturing site (for life): 3003759552.

Event Description

The end user reported that the tab on interlocking closure scratched her leg as soon as it was applied, and it was also described that due to the issue, end user tucked tail into the comfort panel.Additionally, end user stated that since the interlocking closure was not sealed due to which she felt that piece was not secured, and it was feeling rough to her and rubbing onto her skin.Although there was no harm of skin redness or broken skin experienced, however, the issue was embarrassing and frustrating.She used the binder clip to keep the tail closure closed, however, there was no report of paper clip scratching her.A photograph was provided by the nurse to illustrate the issue experienced by the end user.

• Brand Name: ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 17150119
• MDR Text Key: 318038986
• Report Number: 1049092-2023-00166
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455197514
• UDI-Public: 00768455197514
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 421622
• Device Lot Number: 0000809570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2023
• 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 Sex: Female