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

Patient Problems Erythema (1840); Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 12/13/2019

Event Type  Injury  

Event Description

Hospitalization prolonged.Adverse event(s) attributed to: gr.3 infections and infestations, catheter-related "inf." pt status post c1 consolidation (c1d1 on "12/02"), who presents with complaints of pain, tenderness, and edema to her right upper chest port.She had a clinic visit on (b)(6) 2019 where she received a platelet transfusion, and she had no port issues at the time.Exam on admission notable for pain / tenderness, mild edema, slight erythema, no drainage to her right upper chest port site.Chest x-ray negative.Blood culture x2 pending.Started on iv vancomycin empirically on admission.Port site improved in appearance and tenderness.Patient continued on iv vancomycin while cultures were pending.Blood culture x no growth to date on (b)(6) 2019 with stable counts; patient has remained afebrile and port site continues to look stable without erythema or edema.Patient is stable and ready for discharge home; she will complete 7 dy course of doxycycline to cover mrsa infection as well as home prophylactic antibiotics.

• Brand Name: PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• MDR Report Key: 17932261
• MDR Text Key: 325741244
• Report Number: MW5146939
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/09/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2023
• Patient Sequence Number: 1
• Treatment: CYTARABINE 10000 MG
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 53 KG