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

Model Number	421567
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports he has had multiple utis over the 5 yrs he has used this catheter.He said since he started cic 5 yrs ago, he has had utis almost every 3 months.He said only for a year he was on prophylactic cipro and he was uti free for that year however he became allergic to cipro and had to discontinue that.He said his symptoms are always burning and cloudy urine.His md has told him his recurrent utis are most likely not from his catheters but rather from a rare bacterium that has colonized his prostate.He said the bacteria is a common skin bacteria called "epidermidis" which is on the skin and rare to cause a uti but for him they do and the urine cultures show this bacterium over and over again for him.He said usually his md has him do a urine culture and prescribe him doxycycline course for a few days which helps him immediately within 24 - 48 hours he feels better he said on this antibiotic.He is careful to follow all hygiene precautions, always washes hands, cleanses glans, ensures the catheter stays sterile.His md has advised he will need surgery on his prostate to help reduce his infections but so far, he has not opted to have this done.No additional information was provided.This emdr is to address the uti's with unknown lot and market units.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.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.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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 23607665
• Report Number: 3005778470-2025-00803
• Device Sequence Number: 9444428
• Product Code: GBM
• UDI-Device Identifier: 30768455143543
• UDI-Public: 30768455143543
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 421567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/20/2025
• 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: Male