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

Model Number	421570
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr (b)(4) / device 2 of 2 e.1:complainant street address: (b)(6).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
It was reported "packaging defect and tearing".Photos depicting the reported complaint issue were provided by the complainant.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing, packaging and sterilization process had been fulfilled and met the requirements.No nonconformances were identified for this lot.No similar complaint was received for lot 4j00118 and malfunction code ¿uca-pmc11.10 primary pack fractures, cracks, tears, rips or sheds material during opening¿.The machine logbook was checked, and no records related to this issue were found.Additionally, no ncs were identified during the sterilization process.During lot production was used paper supplied by external supplier amcor.During incoming inspection the certificate issued by supplier is inspected and then the paper is released to production.No deviation was observed.This complaint was presented on complaint review board on february 26, 2026.A photograph has been received for this complaint, which was evaluated in accordance with work instruction (b)(4).Packaging defect and tearing is visible in the photo.Attendees decided that this is considered an isolated issue and no further actions are required.Operators will be retrained and the issue will be presented to operators according to (b)(4) qa data visualization (current version).Should additional information become available, a follow-up report will be submitted.Reporting site: 1049092.Manufacturing site: 3005778470.

• 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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 24257047
• Report Number: 3005778470-2026-00227
• Device Sequence Number: 8309378
• Product Code: KOD
• UDI-Device Identifier: 30768455143567
• UDI-Public: 30768455143567
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: Health Professional
• Device Model Number: 421570
• Device Lot Number: 4J00118
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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: Unknown