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
Additional Manufacturer Narrative
Device 2 of 2 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 in the current market unit he has already found qty 2 misaligned is lot 5a00617.He "caths 5 x a day for retention from bph.He states the coude tip and the notch on the funnel end are not perfectly aligned on all catheters.He said this is misaligned by varying degrees, mentioning some are off by 20 degrees sometimes 90 degrees or sometimes even more than 90 degrees.He said 60-70% of them are all aligned well in all his orders but the rest are not.He said when he first started cic and using this product, again about 3-4 yrs ago, he did not realize this misalignment issue and said he remembers it was painful and uncomfortable with insertion of one and felt like there was a sharpness when he was inserting and did say he did experience a "little bit of bleeding" which resolved shortly.He then saw it was due to the misalignment.He knows to keep the coude tip up when inserting and at the time, he was relaying on the notch.He said he learned really quick to not rely on the notch on the funnel and just takes account the misalignment to keep the coude tip itself pointing upwards with insertion and then they work fine for him.".

• 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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24625921
• Report Number: 3005778470-2026-00528
• Device Sequence Number: 15746600
• Product Code: GBM
• UDI-Device Identifier: 30768455153825
• UDI-Public: 30768455153825
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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: 5A00617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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