MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports "he thinks the catheters he was using was a possible source of his multiple utis spanning the length of a year.He reports unknown number of catheters, unknown number of market units with unknown lot numbers of the same catheter over the last 1-2 years.He states that he had 4 utis every few months spanning the length of a year.His last uti was about 7-8 months ago.He states he had been cathing for a total of 3 years and he states only after starting use of the ultram16 he started developing the utis." he was unable to provide timeline specifics when his first uti started after using the ultram16."his signs of uti were always dysuria and malodorous urine.He sought medical treatment with each of his 4 utis and he went to his local urgent care where they did urine testing, ua and urine c & s and prescribed antibiotics each time which helped his symptoms.He followed up with his urologist after so many reoccurring utis and the urologist told him the catheters he was using could be a possible cause of his utis." he confirmed he was always "diligent about hygiene and washed his hands, cleansed his penis prior to cath insertion and followed prior clean intermittent catherization technique." he confirmed "he was only cathing once at night prior to bedtime, as directed by his urologist, but did have urinary retention.Denies any history of bladder or kidney stones.He now states he no longer catheterizes and has a chronic foley catheter placed by his urologist about 7-8 months ago, after his last uti, for continuous drainage and has been uti free since.".

• 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: 13741792
• Report Number: 1049092-2022-00085
• Device Sequence Number: 11969296
• Product Code: OHR
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• Combination Product (Y/N): N
• 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): 03/08/2022

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 Model Number: 510816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/11/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Male