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

Model Number	501004
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr (b)(4) / device 13 of 48 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 reports he feels like he got a defected batch.He said in his latest november order all his catheters he has used so far (has used 48 so far / 52 unused so far from 1 box) feel like they have a ¿sharpness or bur¿ right on the end/ tip area.He can feel it on the catheter with his fingers too.He said he knows right away with initial insertion if they feel like they are scratching him internally.He said he has gotten cut in urethra with use and bled 3-4 x so far because of this.The bleeding stopped on it¿s own each time.He did not need to seek medical intervention.He is taking blood thinners for his heart he said.Consumer is a 75 yr old male, caths 3 a day and has used this product for a long time now with no concerns.
Additional Manufacturer Narrative
Mdr 3005778470-2024-01072 / device 13 of 48.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.The batch record review indicates no discrepancies.Based on the investigation results the issue is considered to be isolated.This issue will be monitored through the post market product monitoring review process, sop-000741.This issue will be monitored through the post market product monitoring review process.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
To date no additional patient or event details have been received.

• Brand Name: GENTLECATH OTHER
• 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: 20920527
• Report Number: 3005778470-2024-01072
• Device Sequence Number: 12859703
• Product Code: KOD
• UDI-Device Identifier: 00768455145478
• UDI-Public: 00768455145478
• Combination Product (Y/N): N
• PMA/510(K) Number: K172924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 501004
• Device Lot Number: 4F05521
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• 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