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

Model Number 421620

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 in an unknown quantity of products, the starter hole 'was cut very jagged'.Normally it had to be cut to the size of the stoma.The one he received looked as though someone had just taken a pair of dull scissors and hand cut the opening.The end user used a razor blade to smoothen this out.It was unknown whether he used the product.There was no harm reported.No photo is available at this time.

• Brand Name: ESTEEM+ FLEX CONVEX
• Type of Device: POUCH, COLOSTOMY
• 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: 9871225
• MDR Text Key: 204626234
• Report Number: 1049092-2020-00110
• 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

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65