MAUDE Adverse Event Report: Unomedical s.r.o. GENTLECATH GLIDE; catheter, urethral

Model Number	421573
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
Event or Problem Description
End user reports she has a lot of bladder/ health concerns mentioning ic and overactive bladder and she constantly has the feeling of a uti, constant burning and irritation is her normal due to her conditions stating she has even tried bladder installations that have not helped her condition in past.She said she last had a diagnosed uti in july.Following the diagnosis and treatment of her uti in july she was placed on methenamine for uti prevention which she said she has had 2 subsequent urine cultures which were negative.Her cultures were not done due to the bleeding event but due to just the overall feeling she always has a uti.She does not take blood thinners but does have history of blood clots/pulmonary embolism in her past.She is planning to follow up with a urogynecologist.No additional information is available.This emdr is to address the uti's with unknown lot and market unit.
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: 3005778470.

• Brand Name: GENTLECATH GLIDE
• Common Device Name: catheter, urethral
• 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: armando cuello ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 50867782
• Report Number: 3005778470-2026-000087
• Device Sequence Number: 18470104
• Product Code: GBM
• UDI-Device Identifier: 30768455143581
• UDI-Public: 30768455143581
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 421573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/23/2026
• 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: 71 YR
• Patient Sex: Female