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

Model Number	421568
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
End user states he has been "cathing for only a months time now for retention from bph that was found in the er as he hadn't been able to void for a few days and had to go to er.He said he feels like certain foods affect his prostate, causing it to swell and felt strongly that a "dandelion sandwich" he ate caused that episode of retention." he said he "preps these catheter by removing the silver water and pouring in the water to prep the catheter.He also removes the blue no touch sleeve as he feels he cannot access enough of the catheter." it was explained to him the proper way to prep the catheter per ifus and that he can slide the no touch sleeve up over the funnel as well.He said so far this catheter has been working well for him and he does not feel that the way he prepped it (not according to ifus) had any impact on this particular concern.He said it slightly uncomfortable going in the length of his urethra but "kind of worse on the way out" feeling it "scrapping him" and noticed he had bleeding afterwards upon removal.He said he felt that catheter with his hands upon removal and felt "jagged spot around the holes (eyelets) and one (eyelet) had what felt like a small pointy thing." he discarded it.He said he estimates he lost about "an ounce of blood" that dripped out but it stopped shortly on its own without intervention.He said he is not on blood thinners.He mentioned this occurred to his urologist but no interventions." he said he has been feeling the eyelets now with clean hands prior to insertion, however he was advised even with clean hands, this could put him at risk for infection as the catheters are sterile and discouraged him to do this.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.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 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: 22344423
• Report Number: 3005778470-2025-00691
• Device Sequence Number: 4901063
• Product Code: KOD
• UDI-Device Identifier: 30768455143543
• UDI-Public: 30768455143543
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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: 421568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 75 YR
• Patient Sex: Male