MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510852
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device 1 of 1.Common device name: cure catheter® for men.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 serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
Product end user with neobladder and catheterizes four or more times per day.Product end user reports that he developed a urinary tract infection and was prescribed two oral antibiotics.End user followed up with his urologist and a cystoscopy was performed and per the end user the doctor used a "spoon to clean out his urethra".The end user reports difficulty inserting the product.According to the end user after the cystoscopy and antibiotics his urine was tested again and was "fine".Unable to determine exact malfunction that could have lead to the alleged urinary tract infections.No photographs received depicting the reported complaint issue.

• 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: 13308963
• Report Number: 1049092-2022-00006
• Device Sequence Number: 17384684
• Product Code: EZD
• UDI-Device Identifier: 00815947020031
• UDI-Public: 00815947020031
• Combination Product (Y/N): N
• Initial Reporter State: MS
• PMA/510(K) Number: K132500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 510852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 84
• Patient Sex: Male