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

Model Number	501003
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) 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 "some of the eyelets on his catheters sharp and painful during insertion and removal.".
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.The process parameters were adjusted within the validated window.No nonconformity has been registered during the manufacturing process of the affected lot and of the mentioned issue.No similar complaint was received on mention lot#3c00806.Percentage of affected pieces against lot is (b)(4).This complaint was first presented to the complaint review board on may 16, 2024, and the investigation started.On may 20, 2024, the attendees decided that no capa is needed.Based on provided information, we cannot consider the sharpness of the eyelet.Operators will be retrained according to g708002 education and training of production personnel and the issue will be presented to operators according to wi-001366 qa data visualization.Affected quantity is within aql 0,65.Based on the investigation results the issue is considered to be isolated.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 3005778470.

• 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: 19181124
• Report Number: 3005778470-2024-00844
• Device Sequence Number: 12620322
• Product Code: KOD
• UDI-Device Identifier: 00768455145461
• UDI-Public: 00768455145461
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 501003
• Device Lot Number: 3C00806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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