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

Model Number 421571

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the catheter tip is sealed with pouch package.The product was not used.

Manufacturer Narrative

E.1: complainant city: (b)(6).Complainant state/province: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.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.

• Brand Name: GENTLECATH GLIDE
• Type of Device: CATHETER, URETHRAL
• 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: 17816261
• MDR Text Key: 324221818
• Report Number: 3005778470-2023-00205
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• PMA/PMN Number: K161344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 421571
• Device Lot Number: 30768455143574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1