MAUDE Adverse Event Report: T-DOC URODYNAMIC CATHETER

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Steris ast received (b)(4) regarding a t-doc urodynamic catheter.The product subject of the medwatch report is not manufactured by steris ast.Steris ast contacted the user facility to determine the manufacturer of the device subject of the medwatch.The medwatch report will be forwarded to the manufacturer of the device for purposes of investigation and evaluation for potential medical device reporting under 21 cfr 803.

Event Description

Reference (b)(4).

• Brand Name: T-DOC URODYNAMIC CATHETER
• Type of Device: CATHETER
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 3303927231
• MDR Report Key: 6549358
• MDR Text Key: 74756132
• Report Number: 1720929-2017-00001
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 04/10/2017
• Type of Device Usage: N
• Patient Sequence Number: 1