MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES, CANADA ULC URODYNAMIC URINARY CATHETER; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number CAT895

Device Problems Increase in Pressure (1491); High Readings (2459)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2021

Event Type  malfunction  

Event Description

Urodynamic catheter malfunctioned leading to reading high pressures.Fda safety report id # (b)(4).

• Brand Name: URODYNAMIC URINARY CATHETER
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
• MDR Report Key: 11207568
• MDR Text Key: 228477990
• Report Number: MW5098931
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2021

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
• Device Operator: Health Professional
• Device Model Number: CAT895
• Device Lot Number: 192516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11 YR