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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON REALIZE GASTRIC BAND
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ETHICON REALIZE GASTRIC BAND Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Erosion (1750); Dysphagia/ Odynophagia (1815); Fainting (1847); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Weakness (2145); Ulcer (2274); Palpitations (2467)
Event Date 01/10/2014
Event Type  Injury  
Event Description
I had a realize adjustable gastric band in for 4 1/2 years.I experienced complications from the band such as nausea, vomiting and pain on/off during that time period.Symptoms progressively increased and on (b)(6) 2014, i had emergency surgery to have band removed.I had been at the doctor's office on (b)(6) 2014 and had all of the saline removed from the band.On (b)(6) 2014, i experienced severe abdominal pain and could not keep any food or liquids down.Since having the removal, i continue to experience difficulty swallowing, nausea, vomiting, palpitations, weakness, and even had a fainting episode at doctor's office on (b)(6) 2014, an unable to tolerate solid foods.I was diagnosed with ulcers, erosive gastropathy and acid esophagitis.I am still in the eval phase and am not certain of what the next step in my treatment regimen is.On 02/14/2014, i was at the bariatric surgeon's office and passed out.I was taken to the er and received iv fluids.
 
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Brand Name
REALIZE GASTRIC BAND
Type of Device
REALIZE GASTRIC BAND
Manufacturer (Section D)
ETHICON
MDR Report Key3651181
MDR Text Key4355102
Report NumberMW5034726
Device Sequence Number1
Product Code LTI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age45 YR
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