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

Model Number	421567
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	Serious Injury
Additional Manufacturer Narrative
E.1: complainant street address: (b)(6).Complainant city: (b)(6).Complainant state/province: (b)(6).Complainant postal code: (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
End user reports he has used our hydrophilic catheters for 5 years.In the last 2 years he says he has had 4 defects- leak at the joint of the envelope.There was no harm reported.No photos were provided.No additional information was provided.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated as type 2 investigation case.No samples or picture were received.A batch record review was conducted resulting in the following: urinary catheter in question was manufactured under sap material id 1713714 - gentlecath glide male ch14 and manufacturing lot#4h04918 in august/ september 2024 in amount (b)(4) pieces on packaging machine p020.Review of the dhr showed that all relevant tests required during the manufacturing, packaging and sterilization process had been fulfilled and met the requirements.Batch record was reviewed and during production was opened no nc.No another complaint was received on lot#4h04918 and malfunction code ¿uca-pmc11.07 primary pack has incomplete or open seal / weld, or is torn, ripped damaged, split, cracked or crushed or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging¿.The machine logbook was checked, and no records related to this issue were found.According to g905704 ver.28.0 work instruction for packaging of gentlecath catheters on p009, p006 and p020¿ 5.11.3 the peel pack must not be sealed in a way that causes the paper and film to separate.The peel packs were inspected in accordance with tm-410 ver.3.0.No discrepancies during production were found.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 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: 22922083
• Report Number: 3005778470-2025-00728
• Device Sequence Number: 21121241
• Product Code: GBM
• UDI-Device Identifier: 30768455143543
• UDI-Public: 30768455143543
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2025

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: 4H04918
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 09/21/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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: Male