MAUDE Adverse Event Report: PORT CHEMOTHERAPY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

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

Patient Problems Abdominal Pain (1685); Death (1802); Unspecified Infection (1930); Pain (1994); Seizures (2063); Swelling (2091); Ambulation Difficulties (2544); Cancer (3262)

Event Date 08/08/2019

Event Type  Death  

Event Description

Heart infection, lung cancer.Mother was constantly in pain having problems using the restroom constantly had flu like symptoms, went to hosp was diagnosed with stage 3 lung cancer and liver failure.Seizures, loss of mobility and speech, excruciating stomach pain, swelling.Failure of digestive system with no bowel movement.Died less than 6 weeks from being diagnosed with cancer and liver failure.Drs stated possible infection from the port installation for chemotherapy.Fda safety report id# (b)(4).

• Brand Name: PORT CHEMOTHERAPY
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• MDR Report Key: 9409919
• MDR Text Key: 169216868
• Report Number: MW5091391
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/30/2019

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 58 YR