MAUDE Adverse Event Report: MFR UNKNOWN N/A; DEVICE, CYSTOMETRIC, HYDRAULIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/13/2013

Event Type  malfunction  

Event Description

Bladder pressure monitoring device malfunction.Discovered that predetermined amount of ns instilled into bladder did not return/drain.Removed device from foley catheter and >300 ml drained from bladder.

• Brand Name: N/A
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): MFR UNKNOWN
• MDR Report Key: 6807554
• MDR Text Key: 83149694
• Report Number: 6807554
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2013,08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2013
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2013
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR