MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	ULTRA M12C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Fda registration number : reporting site: 1049092.Manufacturing site: 3005471919.
Event or Problem Description
End user states "the sides of packaging around catheter are curled in, causes difficulty to open product and causes one to easily contaminate the product upon removal possibly having contributed a uti a few months ago.He said prior to opening these he will swab the tear here end with an alcohol swab just in case upon removal it will come into contact with the outside lettuced edge.He said he has had utis in the past and is so careful to avoid use of these but said he has used some he may have contaminated inadvertently.He feels like this could have possibly contributed to a recent uti several months back.He hasn't had a uti in a while but a few months ago while he was having this issue, he developed a uti.Symptoms were pain in urethra, bladder and lower back as well as rectal pain.He had to go to urgent care for urine testing and get antibiotics (name unknown) to treat it.Has been doing well uti free now." this emdr covers the unknown number of catheters associated with the uti.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 19927694
• Report Number: 1049092-2024-00106
• Device Sequence Number: 14148659
• Product Code: EZD
• UDI-Device Identifier: 00815947021106
• UDI-Public: 00815947021106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221593
• 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): 07/30/2024

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: ULTRA M12C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/07/2024
• 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 Sex: Male