MAUDE Adverse Event Report: ALLERGAN LAP BAND

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 07/23/2014

Event Type  Injury  

Event Description

On (b)(6) 2006 i had an allergan adjustable lap band placed around my stomach.Initially i was able to tolerate the band and lose a substantial amount of weight.It was many years later, beginning around 2012 that i began to experience heartburn symptoms.Since that time i have developed an intolerance of many foods and worsening gerd symptoms.I have been left no choice other than to have my band removed to alleviate my symptoms.I believe the facts and figures regarding the short term and long term outcomes of adjustable banding pts were grossly inaccurate.This has been a despicable injustice that should be stopped for the health and well being of other potential pts.Please take these products off the market for not delivering the success they claim they can deliver (especially in the long term).

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 4006270
• MDR Text Key: 4712513
• Report Number: MW5037714
• 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: 08/06/2014

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: 08/07/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 107