MAUDE Adverse Event Report: URINARY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

Event: home health nurse reported the pt had an indwelling urinary catheter and reported she was recently admitted for uti.The pt received iv antibiotics while inpatient and completed the course.Pt reported increased fatigue and decreased strength to nurse.Initial bp 151/91, then 164/89 at 1115 and bp was 151/88 post infusion.Freq: infuse 20gm (200ml) intravenously every two weeks via curlin pump.Rates as tolerated.Begin infusion at 30ml/hr for 30 mins, then 60ml/hr for 30 mins, then 90ml/hr for 15 mins, to a maximum rate of 120ml/hr.

• Brand Name: URINARY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• MDR Report Key: 18994217
• MDR Text Key: 338937974
• Report Number: MW5153325
• 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: 03/25/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2024
• Patient Sequence Number: 1
• Treatment: B12 COMPLNCE KIT INJ KIT; B12-ACTIVE CHW 1MG; BACLOFEN ; COPAXONE INJ 40MG/ML ; FOLIC ACID TAB 1MG; FOSAMAX TAB 70MG; GAMUNEX-C; HALCION TAB 0.25MG; HEPARIN LOCK FLUSH ; INDERAL LA CAP 80MG
• Patient Outcome(s): Hospitalization
• Patient Sex: Female