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

Model Number	421911
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports the notch and the coude tip was not aligned.The best he could describe is it was off "by a quarter turn." he said he had never noted a concern like that with this product in his past 3 month use of it.He did not use it.There was no harm reported.No additional information 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.Reporting site: 1049092.Manufacturing site: 3005778470.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated.No photo or samples have been received for this complaint.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.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.A capa was opened in november 2022 for incorrect coude tip alignment.As part of the corrective actions, the tolerances for the tip/funnel indicator control were tightened on machines a097 and a116 used for gc glide tiemann production.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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: GENTLECATH
• Common Device Name: CATHETER, UROLOGICAL
• 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: 24549926
• Report Number: 3005778470-2026-00406
• Device Sequence Number: 9485436
• Product Code: KOD
• UDI-Device Identifier: 30768455153832
• UDI-Public: 30768455153832
• 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): 02/27/2026

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: 421911
• Device Lot Number: 5G04811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 07/22/2025
• 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