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

Model Number	421567
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports sharp plastic bur on the end of the catheter that injured them during insertion.End user is a 76-yr old male with bph.He caths 2 x a day and voids regularly throughout the day.He said it was like when you make a plastic model and some of the plastic presses out the sides.He said it was rather sharp but not something he noticed or even looked at carefully prior to insertion.He said it felt uncomfortable but really hurt when he got to his prostate and he didn't continue with it, pulled it out and then noticed this defect.No bleeding at all.He said there was no bleeding but for his next 2 voids it felt like it burned when urine passed but it did not last and dissipated on its own.He said " i don't see myself as harmed from this." a photo was provided.
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.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated.A photograph has been received for this complaint and was evaluated.Deformed catheter tip is visible on the photo.Review of the dhr showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lot.No other complaint was received to this lot.The batch record review indicates no discrepancies.This complaint was presented to the complaint review board.Attendees decided that this is considered an isolated issue and no further actions are required.The issue will be monitored.Operators will be retrained according to education and training of production personnel (current version) and the issue will be presented to operators according to qa data visualization (current version).This issue will be monitored through the post market product monitoring review process.Fda registration number.Reporting site: 1049092.Manufacturing site: 3005778470.
Event or Problem Description
To date no additional patient or event details have been received.

• 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: 23556758
• Report Number: 3005778470-2025-00793
• Device Sequence Number: 9660004
• Product Code: GBM
• UDI-Device Identifier: 30768455143543
• UDI-Public: 30768455143543
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 421567
• Device Lot Number: 5A00534
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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 Age: 76 YR
• Patient Sex: Male