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
Event or Problem Description
End user reports his catheters "tip coude is misshapen - shorter bend that is not aligned to notch on funnel".No photo available.There was no harm reported.
Additional Manufacturer Narrative
A2: sex: male 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
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, 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.No further action is required.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.

• 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 ; 3365424679
• MDR Report Key: 18738007
• Report Number: 3005778470-2024-00705
• Device Sequence Number: 15186999
• Product Code: KOD
• UDI-Device Identifier: 00768455145539
• UDI-Public: 00768455145539
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/16/2024

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
• Device Lot Number: 3B00221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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: Unknown