MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports "the catheters caused him to have a uti.His uti symptoms were nausea, cloudy urine, frequency and urgency of voiding only cathing out small amounts frequently." he states he used "several cs14 catheters for 1 week, same reference number, unknown market units, unavailable lot numbers.He is very familiar with the closed system catheters and is following proper catherization technique.He is handwashing prior to cathing, using gloves and wipes head of penis with antibacterial wipe prior.He is mindful not to touch the catheters on anything when/prior to inserting catheter.Wife states he has had a history of multiple utis in the past even when using his usual bard catheters.He has diagnosis of ckd iii.He called his doctor and they had him go to outpatient lab for urine testing , urinalysis and urine culture and he was prescribed an antibiotic which cleared up his uti symptoms.He discontinued use of catheter and has his regular bard catheters back that he wishes to continue using.".

• 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: 13669641
• Report Number: 1049092-2022-00083
• Device Sequence Number: 20202538
• Product Code: FCM
• UDI-Device Identifier: 00815947020673
• UDI-Public: 00815947020673
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: 510801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/04/2022
• 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: 79
• Patient Sex: Male