MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. REALIZE BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Bronchitis (1752); Urinary Tract Infection (2120); Weight Changes (2607); No Code Available (3191)

Event Date 03/01/2009

Event Type  Injury  

Event Description

A reporter said that she had realize band implanted early march for weight loss.Reporter said she went to a seminar and got all the information and instructions and started working out like kickboxing.Reporter said she did not lose any weight but did not gain any.The reporter said she got frustrated and went to see a bariatric doctor, who emptied the fluid from the port that goes into the band.Reporter said no matter how much she eats, she is constantly hungry.Also cannot keep food down especially meat, which she needs for her protein intake.She was also having acid reflex issues, bronchitis every other month and urinary tract infection.Finally, reporter went to the same doctor and asked the implant to be removed.Reporter stated once the implant was removed, most of her symptoms have improved.She is currently having issues like: vision problems, asthma, fatigue, weakness and hardly leave her house and she gained about 12 pounds.

• Brand Name: REALIZE BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC. ; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 10043089
• MDR Text Key: 190663119
• Report Number: MW5094440
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• 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: 05/08/2020

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: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 100