MAUDE Adverse Event Report: CONVATEC INC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

It was reported "consumer is getting uti not sure if its catheter related." no part or lot number information was provided.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Complainant was unable to provide the model number, lot number or product sizing information, therefore 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: reporting site: (b)(4).Manufacturing site: (b)(4).

• 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: 15668073
• MDR Text Key: 302397323
• Report Number: 1049092-2022-00387
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2022
• 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: 74
• Patient Sex: Male