MAUDE Adverse Event Report: C. R. BARD, INC. BARD SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number A897516

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 07/11/2018

Event Type  malfunction  

Event Description

Removed foley catheter; pt experienced pain/burning while removing catheter.

• Brand Name: BARD SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 7709858
• MDR Text Key: 114851258
• Report Number: MW5078505
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/18/2018
• 3 Devices were Involved in the Event: 1 2 3

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: A897516
• Device Catalogue Number: A897516
• Device Lot Number: NGCP1831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1