MAUDE Adverse Event Report: INAMED HEALTH/ ALLERGAN/ APOLLO ENDOSURGERY INC. GASTRIC LAB BAND

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Fever (1858); Pneumonia (2011); Vomiting (2144)

Event Date 12/03/2016

Event Type  Injury  

Event Description

I had a gastric band that caused my problems.It was first placed in (b)(6) 2005, then it was replaced (b)(6) 2012.My problems got worse after the second band was placed.I was never able to eat properly again, and i had vomiting spells constantly along with chest pain and upper abdominal pain all the time.I was hospitalized multiple times because of the side effects from this.On (b)(6) 2016 i had aspiration pneumonia with a fever of 106.

• Brand Name: GASTRIC LAB BAND
• Type of Device: GASTRIC LAB BAND
• Manufacturer (Section D): INAMED HEALTH/ ALLERGAN/ APOLLO ENDOSURGERY INC.
• MDR Report Key: 6215328
• MDR Text Key: 63717818
• Report Number: MW5066989
• 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: 12/28/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 120