MAUDE Adverse Event Report: LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Autoimmune Disorder (1732); Nausea (1970); Pain (1994)

Event Date 06/01/2012

Event Type  Injury  

Event Description

I got the lap band in 2012.I started off without ever having had acid reflux and was told by the surgeon that my esophagus was perfect, now it's my daily life.I was diagnosed with an auto immune disease but the drs could only tell me which ones, it wasn't (no prior family history, no prior symptoms).I also developed degenerative disk disease when i had never before had back issues.I have constant nausea and often have pain at the port site.

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• MDR Report Key: 7801804
• MDR Text Key: 117956546
• Report Number: MW5079269
• 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: 08/16/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 82