MAUDE Adverse Event Report: ETHICON US, LLC REALIZE BAND

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011); Hernia (2240); Prolapse (2475); No Code Available (3191)

Event Date 02/12/2015

Event Type  Injury  

Event Description

I had a realize band installed in 2009, despite being a "model pt" the device slipped in 2010 and i had it surgically repaired.Device was causing acid reflux so i had the device unfilled for years.In 2014 i started to experience severe gerd, developed aspiration pneumonia and had a ct scan and upper gi that determined that i had a severe prolapse and hiatal hernia which resulted in a surgery to have the realize band surgically removed.

• Brand Name: REALIZE BAND
• Type of Device: REALIZE BAND
• Manufacturer (Section D): ETHICON US, LLC
• MDR Report Key: 4540980
• MDR Text Key: 5358227
• Report Number: MW5040852
• 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: 02/16/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 93