MAUDE Adverse Event Report: ALLERGAN TRUE RESULTS LAPBAND 10CC

Device Problem Device Slipped (1584)

Patient Problems Flatus (1865); Swelling (2091); Vomiting (2144)

Event Date 07/07/2015

Event Type  Injury  

Event Description

I had the true results 10cc lapband put in around my stomach (b)(6) 2004.After year and half i had problems keeping food down (throwing up) and bad acid reflux day and night plus aspiration at night.Had several untighten and tighten by saline injections with no help.Problems never went away the whole time i had the lapband.On (b)(6) 2015 my lapband completely failed me.No restrictions and something was wrong.Had lapband taken out (b)(6) 2015.The doctor told me lapband slipped up off my stomach onto my esophagus causing massive swelling.

• Brand Name: TRUE RESULTS LAPBAND 10CC
• Type of Device: LAPBAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 4924408
• MDR Text Key: 6012714
• Report Number: MW5044399
• 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: 07/09/2015

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: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 124