MAUDE Adverse Event Report: BARD BARD FOLEY CATHETER, 16F

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Hyperventilation (1910); Memory Loss/Impairment (1958); Pain (1994); Seizures (2063); Anxiety (2328); Coma (2417); Constipation (3274)

Event Date 01/01/2009

Event Type  Injury  

Event Description

Rptr had a heart attack this year and began requesting her medical records to find out what would cause her problems.She became aware of that in 2009, when she had surgery to have her fibroids removed she also had a heart attack.She was supposed to just have the fibroids removed but they were so big they had to do a hysterectomy as well.The doctor placed a foley catheter and it apparently malfunctioned when it could not be flushed.According to patient she was never notified of the malfunction, nor that she had a heart attack.She has experienced seizures, anxiety, hyperventilation, pain, tarry stools, constipation, short term memory problems and bleeding bowels.She had to have multiple blood transfusions.After the heart attack this year, she was implanted with a defibrillator on (b)(6) 2014.During this incident she was in a coma for 10 days and flat-lined four times.She has had lots of problems obtaining her medical records in order to find out the full extent of what happened.She feels it is because there is a question whether her problems, especially anxiety, is named the cause of her heart attacks as opposed to being a result of the medical device/foley malfunction.She also believes that her sinus attacks have worsened and caused blood to back up out of her bowels, that were bleeding and had old blood, which caused her heart attack and bradycardia.

• Brand Name: BARD FOLEY CATHETER, 16F
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): BARD
• MDR Report Key: 4277182
• MDR Text Key: 5225439
• Report Number: MW5039229
• Device Sequence Number: 1
• Product Code: EZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 75