MAUDE Adverse Event Report: CONVATEC INC L3O0675 - ESTEEM+; I

Model Number 421615

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 serious injury.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.Fda registration number: (b)(4).

Event Description

The end user had cut wafer stoma opening in 1 out of 10 appliances from a sample pack, at 35-40 mm.Since this was a flexible convex, she stated the appliance moved with her body resulting in the wafer stoma opening cutting her stoma.One-fourth of her stoma protruded and this was the area that was cut.Reportedly, the product was not rough or jagged.She discontinued using the product, returned to a non-company product and the issue resolved without further intervention.Her stoma was oval and measured 35-40 mm.There was no report of stoma obstruction from the product.No photo is available at this time.

• Brand Name: L3O0675 - ESTEEM+
• Type of Device: I
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 11070524
• MDR Text Key: 223714471
• Report Number: 1049092-2020-00186
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/23/2020
• 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: 44