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

Model Number	421566
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
End user reports "some of the gc glides included in the sample pack felt particularly uncomfortable, "stating there was a scratching/pinching sensation 6 to 8 inches into insertion of catheter" he said it felt like around the eyelets there was a "hangnail on there" with insertion.He did not force them in further when he felt this and removed them.He did not experience any bleeding.No harm reported.He did not examine the catheters after removal to see or feel with his hand if there were any deformities on the eyelets or on the catheter as he felt with insertion.He said he has very calloused hands and likely wouldn't have been able to feel any subtle defects anyways.He discarded them.He was also prepping them correctly as well prior to use." this emdr covers the unknown number of catheters associated with the defects.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing and packaging process and final product release had been fulfilled and met the requirements.No nonconformances were identified for this lot.No similar complaint has been received on lot 5h04671 and malfunction code uca-pmc07.02 catheter shaft, balloon, tip or eyelets too rough/jagged edges or too sharp.Affected quantity is (b)(6) percent ((b)(6)), which is within the 04-aql limit applicable to this type of issue.The process parameters were adjusted within the validated window.The machine logbook was reviewed, and no records related to this issue were found.Additionally, no ncs were identified during the sterilization process.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.

• Brand Name: GENTLECATH GLIDE
• 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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24755387
• Report Number: 3005778470-2026-00545
• Device Sequence Number: 9100997
• Product Code: KOD
• UDI-Device Identifier: 30768455143536
• UDI-Public: 30768455143536
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K161344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 421566
• Device Lot Number: 5H04671
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 08/28/2025
• 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: 63 YR
• Patient Sex: Male