MAUDE Adverse Event Report: REALIZE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Chest Pain (1776); Nausea (1970); Swelling (2091); Vomiting (2144); Arthralgia (2355); Respiratory Tract Infection (2420)

Event Date 04/21/2011

Event Type  Injury  

Event Description

I had a lap band put in back in (b)(6) 2011.I just had it removed on (b)(6) 2015.I was never able to tolerate getting fills.My stomach/esophagus swelled where the band was and started causing chest pain, nausea, vomiting, joint pain and a chronic annoying cough.Whenever i ate anything, it sat in my esophagus for hours before moving into my stomach, giving me pain in my stomach, chest and upper body.I am two weeks out from my band removal and am still having some problems.I will probably be seeing a gastroenterologist and have an endoscopy done to see if i have any internal damage/issues going on.

• Brand Name: REALIZE
• Type of Device: REALIZE
• MDR Report Key: 5250206
• MDR Text Key: 32182759
• Report Number: MW5058132
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/22/2015

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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ESTROGEN PATCH
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 122