MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports he "performs intermittent urinary self-catheterization several times a day for the past several years due to neurogenic bladder after he broke his neck.He uses the magc go catheter which is on bo and he is currently using sub ultram14c.Unknown quantity of ultram14c." end user states "the coude tip is at a different angle than the magic go and the lubricant is "very sticky" and this causes discomfort when inserted into his urethra.He developed a burning feeling to the urethra with catheterization and voiding.He saw his hcp who did a urine culture which showed a urinary tract infection uti" for which end user was prescribed cipro oral antibiotic x 10 days.End user further states he is "well aware of hygenic standards" with the catheterization procedure and does not feel his technique resulted in the uti.The burning has resolved.

• 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: 13636884
• Report Number: 1049092-2022-00071
• Device Sequence Number: 2124637
• Product Code: GBM
• UDI-Device Identifier: 00815947021113
• UDI-Public: 00815947021113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

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: 06/28/2024
• Device Model Number: 510815
• Device Lot Number: 210715-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male