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

Model Number	421910
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports coude tip and notch on funnel not aligned and caused bleeding with use.He states he has been using this product for many years and this catheter worked well for him previously.He states he got one box where every catheter he used had this defect, having used 21 or 22 of them.He discarded 8 or 9 of them from this box without using or checking them for this defect from this box.He reports the coude tip and the notch on funnel were all off, misaligned by about 90 degrees.Due to this misalignment, he experienced some bleeding with the first one used.The bleeding stopped quickly without intervention, and it was caused because it was very difficult to put in due to this issue and he didn't realize the misalignment with first one used with the defect.He has been using this product for many years and never had this happen before.Once the catheter was removed, he could see the misalignment.From the notch on the funnel the coude tips appear to be pointing 90 degrees to the left.No photo available.No additional information was provided.
Additional Manufacturer Narrative
Device 18 of 22 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
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Device 18 of 22.Investigation: this complaint has been evaluated.No photo or samples have been received for this complaint.No nonconformances were identified for this lot.The machine logbook was reviewed, and no records related to this issue were found.Additionally, no ncs were identified during the sterilization process.All raw materials used in the production of the affected lots were verified to be correct and within specification.No nonconformances were identified during the production of these lots.Process and quality checks were performed and documented in accordance with standard procedures.No manufacturing-related root cause was identified.This issue will be monitored through the post market product monitoring review process, (b)(4).Fda registration number: reporting site: 1049092.Manufacturing site: 3005778470.

• Brand Name: GENTLECATH
• 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 ; 6032470255
• MDR Report Key: 24469614
• Report Number: 3005778470-2026-00391
• Device Sequence Number: 10332080
• Product Code: GBM
• UDI-Device Identifier: 30768455153825
• UDI-Public: 30768455153825
• Combination Product (Y/N): N
• PMA/510(K) Number: K181206
• 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,Followup
• Report Date (Section B): 02/20/2026

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: 421910
• Device Lot Number: 5F04265
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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 Sex: Male