MAUDE Adverse Event Report: UNOMEDICAL S.R.O. CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	ULTRA M16C
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on supplier investigation: for uti (urinary tract infection) of ultram16c: not cleaning meatus prior to insertion allowed bacteria going into the urethra/bladder which bring uti.For uti (urinary tract infection) of the m16c: without lubricant, the friction during insertion caused damaged to the urethral mucosa, meanwhile, he didn¿t clean meatus prior to insertion allowed bacteria going into the urethra/bladder which brink uti.From the above root causes, we can conclude this to be a misuse by the service user, hence no corrective and preventive action to be taken now.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
To date no additional patient or event details have been received.
Event or Problem Description
It was reported, a 'consumer had a uti shortly after use' of this catheter.No additional information was provided.
Additional Manufacturer Narrative
A2: sex, male.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.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 18923526
• Report Number: 1049092-2024-00026
• Device Sequence Number: 12641176
• Product Code: EZD
• UDI-Device Identifier: 00815947021120
• UDI-Public: 00815947021120
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 M16C
• Device Lot Number: 22B25404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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: Unknown