MAUDE Adverse Event Report: LAP BAND

Device Problem Filling Problem (1233)

Patient Problems Aspiration/Inhalation (1725); Autoimmune Disorder (1732)

Event Type  Injury  

Event Description

Got my lap band in 2006.Had a lot of acid reflux problems had to take acid reflux medicine daily.Had it unfilled when i got pregnant with my son in 2008 and all of the fluid that was reported to be in the band did not come out.When i had son in 2009, i went back to get filled.My acid reflux problems were so bad that i was aspirating into my lungs when i was asleep at night.So i had to get unfilled and have been that way since.Even unfilled, i still have some acid reflux problems.In the last year and a half i have developed autoimmune symptoms and fibromyalgia and have been advised by my rheumatologist that i need to get this lap band removed to see if it is causing my problems.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 4577287
• MDR Text Key: 5479234
• Report Number: MW5041232
• 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: 02/27/2015

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: 02/27/2015
• Patient Sequence Number: 1
• Treatment: TRAMADOL; TIZANIDINE; MOBIC; LOW DOSE NALTREXONE; PLAQUINIL; NORCO; AMLODOPINE
• Patient Outcome(s): Disability
• Patient Weight: 100