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

Model Number	421567
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports some of the packaging wasn¿t sealed correctly so when the water sachet was popped it would leak.No photo was available.There was no harm.No additional information was provided.This emdr covers the unknown qty from this lot #.
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: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation: 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 similar complaint was received to this lot and malfunction code.The batch record review indicates no discrepancies.This issue will be monitored through the post market product monitoring review process, (b)(4).Fda registration number: reporting site: 1049092, manufacturing site: 3005778470.

• 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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24754271
• Report Number: 3005778470-2026-00542
• Device Sequence Number: 15648518
• Product Code: GBM
• UDI-Device Identifier: 30768455143543
• UDI-Public: 30768455143543
• 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): 03/25/2026

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: 421567
• Device Lot Number: 5J03706
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 09/18/2025
• 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: Unknown