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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Discomfort (2330)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports, unknown qty "almost everyone" in 1 mu box, the coude tip and notch on funnel not aligned causing discomfort and had bleeding with use.Consumer has self cath'd for the past 6 months, off and on, with this product.He states he has had 6 total surgeries for urethral scar tissue and turp procedures in his past.His most recent surgeries were in october of last year and this year on (b)(6).He started cic last year after his october procedure and he was advised to start to self -cath once every day for a month following the procedure and tapering down for the next 2 months until stopping the need to cath.His scar tissue returned badly this year and now after his most recent surgery in feb, he has been advised by his urologist to cath at least once a day to drain bladder but also to keep scar tissue dilated and open.He notes that in his recent box almost every catheter in the box was misaligned by about 45 degrees.He said if you look at the line on the notch on the funnel on top, the coude tip is pointing to the left about 45 degrees.He said passing these with misalignment can cause discomfort and he did have some bleeding this week with use of these daily, noting little scabs as well in drainage of urine with the blood, some drops of blood.Occurs with cathing.He is not sure if this defect causing him that increased discomfort and that is what caused the increased bleeding this past week as he typically does not have bleeding.He has experienced bleeding rarely in the past with cic but thinks that was just due to healing from his surgeries and that known scar tissue as he passes the catheters to help dilate it.He does sometimes note some difficulty passing through his sphincter into the bladder and does deep breathing to help this.No photo available.No additional information was provided.This emdr covers the unknown number of catheters for this malfunction associated with this lot and market unit.
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.

• 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: 25008554
• Report Number: 3005778470-2026-00582
• Device Sequence Number: 18466627
• Product Code: GBM
• UDI-Device Identifier: 30768455153825
• UDI-Public: 30768455153825
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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: 5F01409
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 05/23/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/23/2026; 06/01/2026
• Date Device Manufactured: 06/06/2025
• 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