MAUDE Adverse Event Report: ALLERGAN LAPBAND; GASTRIC BAND

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Weight Changes (2607)

Event Date 07/02/2015

Event Type  Injury  

Event Description

I had lap band surgery in 2009 and due to the current medical problems (acid reflux, vomiting, weight gain, abdominal pain and chronic indigestion) i am told i will need to have it removed.At the time of the surgery, i was advised that this procedure would be a permanent way to control my weight and that it can be adjusted.I was told at that time that the percentage of patients who had problems or needed reversal was less than 1%.I not only gained the weight but have medical issues as a result.

• Brand Name: LAPBAND
• Type of Device: GASTRIC BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 4905784
• MDR Text Key: 16907663
• Report Number: MW5043928
• 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: 07/03/2015

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 46 YR
• Patient Weight: 100