MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510863
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Urinary Tract Infection (2120); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports she "performs intermittent urinary self-catheterization every 4-6 hrs due to retention for the past 30 years." end user reports the "cure f14 is 5 ¼¿ long (end of hub to tip of catheter) instead of 6¿ as noted on the package and she feels she does not empty completely because of this and attributes the 3 urinary tract infections uti¿s she has had since (b)(6) 2022 to this issue.Uti symptoms reported to her hcp included burning with voiding, back pain, low grade fever.A urine culture and blood work were done.She was given 3 courses of oral antibiotic - macrobid x 1 and currently completing a course of cephelex.".

• 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: 13636989
• Report Number: 1049092-2022-00068
• Device Sequence Number: 5201874
• Product Code: KOD
• UDI-Device Identifier: 00815947020215
• UDI-Public: 00815947020215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080881
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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 Expiration Date: 12/01/2025
• Device Model Number: 510863
• Device Lot Number: 210108-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female