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

Model Number	421570
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
End user states "she has no feeling in urethra/ bladder and is paralyzed.She said she found about 4 catheters affected and only used 1 with the concern before noting the defect.Using that one affected made her bleed so she did not use them anymore and would check them prior to use.She said it was like the end of the catheter was pressed into the side by the seals of the packaging making the catheter compressed near tip and sharp.She first said these affected were hard to pull out prior to use and she used the first one like this as she didn't look at it prior and it caused her to bleed, she said off and on for weeks before finally resolving.She is on blood thinners so she said this made the bleeding worse.She said in that order from multiple boxes she found another 3 catheters that were like this as she could tell they were stuck "off to the side, stuck where they were pressed together" and by that she meant the catheter packaging seals on sides near tip.She did not use them and discarded them.".

• 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: 20304085
• Report Number: 3005778470-2024-00950
• Device Sequence Number: 18352328
• Product Code: KOD
• UDI-Device Identifier: 30768455143567
• UDI-Public: 30768455143567
• 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): 09/23/2024

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: 421570
• 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: 09/23/2024
• Initial Report FDA Received Date: 09/25/2024
• 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 Sex: Female