MAUDE Adverse Event Report: UNKNOWN FEEDING TUBE; TUBE, FEEDING

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

Patient Problem Unspecified Infection (1930)

Event Date 04/03/2023

Event Type  Injury  

Event Description

Patient was admitted to the hospital for severe infection of the blood and tissue due to infection of the feeding tube.Patient is currently in the hospital and has been there since (b)(6) 2023.

• Brand Name: FEEDING TUBE
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17040168
• MDR Text Key: 316443556
• Report Number: MW5118038
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/26/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN 500MG.; HEPARIN.; METHOCARBAMOL 500MG.; MIDODRINE 5MG.; MYCOPHENOLATE, 200MG/1 MG/ML-MILLIGRAMS PER MILLILITERS.; PREDNISONE 5MG.; SERTRALINE 50MG.; TACROLIMUS, 5 MG MILLIGRAM(S).
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male