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

Model Number	421622
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Distress (2329); Discomfort (2330)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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+
• Common Device Name: 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
• Report Number: 1049092-2023-00166
• Device Sequence Number: 3941451
• Product Code: EZQ
• UDI-Device Identifier: 00768455197514
• UDI-Public: 00768455197514
• Combination Product (Y/N): N
• Initial Reporter State: ME
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 421622
• Device Lot Number: 0000809570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female