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

Model Number	501014
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 reports "the indicator line on the funnel not aligned with the coudé tip.This makes the use of the coudé catheter more difficult.In order to use the catheters, he is marking the catheter on the funnel end with a line acting as the indictor line for the coudé tip." unknown actual quantity of affected catheters and no lot number provided.

• 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: 19646191
• Report Number: 3005778470-2024-00895
• Device Sequence Number: 6587244
• Product Code: KOD
• UDI-Device Identifier: 00768455145539
• UDI-Public: 00768455145539
• 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
• Report Date (Section B): 06/25/2024

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: 501014
• 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: 06/25/2024
• Initial Report FDA Received Date: 07/01/2024
• 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: Male