MAUDE Adverse Event Report: UNKNOWN FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 03/02/2023

Event Type  Injury  

Event Description

An 80-year-old patient was sent to the hospital for decreased responsiveness and hypotension on (b)(6) 2023.Upon return on (b)(6) 2023, prn alprazolam 0.125 mg tablet was stopped due to their multiple hospitalizations since starting it.Alprazolam was subsequently replaced with quetiapine which has been extremely helpful.Md added alprazolam to the patient's allergy list.On (b)(6) 2023, patient was seen for mental status changes and hypotension thought secondary to his chronic indwelling foley catheter.He was sent to hospital for probable sepsis with mental status changes and hypotension.Likely source is either chronic foley or aspiration.Hospital hypothesized that possibly he was having mental status changes and urinary organisms found are colonizers vs.Pathogens.This was rated as possible.Schizophrenia, other specified personality disorder, hypertension, metabolic syndrome, type 2 diabetes mellitus with diabetic neuropathy.Anxiety.

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17109979
• MDR Text Key: 317127211
• Report Number: MW5118337
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): Y
• 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: 06/07/2023

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?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White