MAUDE Adverse Event Report: UNOMEDICAL S.R.O. GENTLECATH GLIDE; CATHETER, URETHRAL

Model Number	421573
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.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.
Event or Problem Description
End user reports, "cath tip is rough and caused bleeding." no further information obtained.No photo available.

• 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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 22092241
• Report Number: 3005778470-2025-00546
• Device Sequence Number: 7885598
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 421573
• Device Lot Number: 4H04759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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