MAUDE Adverse Event Report: PEG TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

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

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Urinary Tract Infection (2120); Thrombosis/Thrombus (4440); Osteomyelitis (4533)

Event Type  Injury  

Event Description

Back in april, when pt was on mavenclad, she developed a sore on the base of her spine which was removed and believed to be osteomyelitis.In the early fall, she went to the emergency room and a dvt (deep vein thrombosis) was found.She had anemia, issues with peg tube, hypotension, and other problems at the hospitalization a few weeks ago.They also did iv abx for the osteomyelitis.Last week she went to the emergency room because they thought there was a leak in the peg tube, but there was not.As of now, she has a uti (urinary tract infection).

• Brand Name: PEG TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 16205073
• MDR Text Key: 307819444
• Report Number: MW5114387
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• 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?: No
• Patient Sequence Number: 1
• Treatment: "IV ANTIBIOTICS"; KESIMPTA PEN; MAVENCLAD
• Patient Outcome(s): Hospitalization
• Patient Sex: Female