MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number 510851

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

Consumer reports that he developed a urinary tract infection while using the catheters in (b)(6) 2021.He states that he has been catheterizing for the past 12 years 3 times per day through his penis into his neobladder for urinary retention.He reports that he washes his hands with soap and water prior to catheterizing.He then washes his penis using a sanitizing wipe.He uses a tube of lubricating gel applied to catheter and recapped.He holds the catheter and inserts the catheter but reports he has to touch the entire catheters as he advances the catheter.

Manufacturer Narrative

Device 1 of 1.Common device name: cure catheter for men & women.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.Based on the available information, this event is deemed to be a reportable malfunction/serious injury.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).

• Brand Name: L3C0600 - CURE PRODUCTS
• 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: 13394568
• MDR Text Key: 289255052
• Report Number: 1049092-2022-00009
• Device Sequence Number: 1
• Product Code: EZD
• UDI-Device Identifier: 00815947020024
• UDI-Public: 00815947020024
• Combination Product (y/n): N
• PMA/PMN Number: K132500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 510851
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male