MAUDE Adverse Event Report: GENENTECH PORT DELIVERY SYSTEM; PORT-A-CATH IMPLANTED, SUBCUTANEOUS INTRAVASCULAR

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

Patient Problem Pneumonia (2011)

Event Date 02/29/2020

Event Type  Injury  

Event Description

Pt was hospitalized for pneumonia.Fda safety report id# (b)(4).

• Brand Name: PORT DELIVERY SYSTEM
• Type of Device: PORT-A-CATH IMPLANTED, SUBCUTANEOUS INTRAVASCULAR
• Manufacturer (Section D): GENENTECH
• MDR Report Key: 9834798
• MDR Text Key: 183738460
• Report Number: MW5093754
• Device Sequence Number: 1
• Product Code: LJT
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR