MAUDE Adverse Event Report: IV PORT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

Patient stated she had a 5-day stay at the local hospital last week.Her oncologist isn't sure if it's due to the ziextenzo or the iv port she just had placed in which might have caused an infection at the port site.Pt went to hospital due to flu-like symptoms such as aches/pain.Pt was told her lactic acid levels were elevated.She stated her oncologist is fully aware of everything and she takes her next shot next week and the oncologist will monitor her.Unknown exact dates of hospitalization.No further information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: IV PORT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 15259129
• MDR Text Key: 298410481
• Report Number: MW5111602
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 08/17/2022

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: 08/18/2022
• Patient Sequence Number: 1
• Treatment: ZIEXTENZO PFS 6 MG/0.6 ML, MFR: SANDOZ
• Patient Outcome(s): Hospitalization
• Patient Sex: Female