MAUDE Adverse Event Report: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Unspecified Infection (1930); Discomfort (2330); Disability (2371)

Event Date 05/27/2015

Event Type  Injury  

Event Description

My wife had lap band surgery through the (b)(6) clinic in (b)(6) back in 2008.In 2013 she was told everything was perfect and even though they weren't performing this surgery anymore they didn't suggest removing it.My wife is now recovering from emergency surgery because it eroded into her stomach and had to be removed.She is in pain and discomfort and is now fighting an infection and has missed 3 weeks of work.It appears that erosion isn't too uncommon with this product so how the heck can this device be approved if it is causing so much pain and suffering? it started on (b)(6) with a call to 911.She had surgery on (b)(6).

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
• Type of Device: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
• MDR Report Key: 4867482
• MDR Text Key: 5864084
• Report Number: MW5043203
• Device Sequence Number: 1
• Product Code: LTI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 79