MAUDE Adverse Event Report: Unomedical s.r.o. GENTLECATH TIEMANN; Catheter, Urological

Model Number	501014
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction

• Brand Name: GENTLECATH TIEMANN
• Common Device Name: Catheter, Urological
• 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: pam meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 50758465
• Report Number: 3005778470-2026-000086
• Device Sequence Number: 21142605
• Product Code: KOD
• UDI-Device Identifier: 00768455145539
• UDI-Public: 00768455145539
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 501014
• Device Lot Number: 5M02228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2025
• 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