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

Model Number	421565
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1: (b)(6).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
It was reported the catheter tip is sealed with pouch package.The product was not used.
Additional Manufacturer Narrative
No sample or picture was provided to the complaint.The issue has been monitored and because the several complaints of this nature had been received memo with list of complaints has been summited to crb.Conclusion made on crb meeting held on 3-nov-2023.The defect occurrence is small in each mentioned complaint.The defect is clearly visible and was detected by users before use.No harm was reported.According to ifu ?(b)(4):.¿ do not use the device if the packaging or the water sachet is damaged or open prior to use and dispose of the device according to local regulations.¿ based on above crb attendees took a decision that no further actions are required at this stage.The issue will be continued to be monitored.In case of increased trend, the issue will be submitted to crb.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 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 ; 3365424679
• MDR Report Key: 17938574
• Report Number: 3005778470-2023-00270
• Device Sequence Number: 19572596
• Product Code: KOD
• UDI-Device Identifier: 30768455143529
• UDI-Public: 30768455143529
• Combination Product (Y/N): N
• PMA/510(K) Number: K161344
• 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): 10/13/2023

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 Expiration Date: 08/01/2025
• Device Model Number: 421565
• Device Lot Number: 2J01936
• 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): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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