MAUDE Adverse Event Report: CONVATEC INC L3O0675 - ESTEEM+

Model Number 421623

Device Problem Sharp Edges (4013)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

Common device name: pouch, colostomy.Mfr site: (b)(4).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).

Event Description

The end user reported that his wear time was 3 days but he wanted to return to 4-5 days.When the end user had cut the wafer stoma opening, it was jagged and this resulted in bleeding to the peristomal skin or the stoma.The blood did collect in the pouch.He spoke with his doctor regarding the issue and the doctor gave him an over the counter spray (name unknown) to use.The end user continued to use the product.He was unable to say if he had used non-convex product before.He was unable to verify stoma size but previous documentation was 40mm.No photo is available at this time.

• Brand Name: L3O0675 - ESTEEM+
• 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: 12195653
• MDR Text Key: 262482801
• Report Number: 1049092-2021-00079
• 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: 06/23/2021

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
• Device Operator: No Information
• Device Model Number: 421623
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73