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
Event or Problem Description
It was reported, a 'consumer had a uti shortly after use' of this catheter.Consumer said there was nothing wrong with the ultram16c catheter it was not defective it was just him as he inserted it without much practice the first few times that caused his uti.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 ; 3365424679
• MDR Report Key: 18921231
• Report Number: 1049092-2024-00025
• Device Sequence Number: 17744995
• 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
• Report Date (Section B): 03/04/2024

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 Expiration Date: 10/28/2025
• Device Model Number: ULTRA M16C
• Device Lot Number: 22B26902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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