MAUDE Adverse Event Report: Unomedical s.r.o. GENTLECATH AIR; Catheter, Urethral

Model Number	510691
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Distress (2329)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported '"the catheter itself has been glued to the bottom of the envelope, making it very difficult or impossible to remove -- often causing the water from the enclosed pouch to spill.I don't use them often, but in the situations where this happens it is extremely inconvenient, time-consuming, or even embarrassing.I only found this defect in a handful of items.It looked like the "heat spot weld" in the package center (which i assume is to keep the tube coiled) was misplaced and it caught part of the turn or the sliding sleeve." this emdr covers the unknown number of catheters associated with the defect.
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.

• Brand Name: GENTLECATH AIR
• 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: pam meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 50752892
• Report Number: 3005778470-2026-000086
• Device Sequence Number: 18529453
• Product Code: GBM
• UDI-Device Identifier: 00768455196302
• UDI-Public: 00768455196302
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/30/2026

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: 510691
• Device Lot Number: 5E06140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown