MAUDE Adverse Event Report: LAP BAND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aspiration/Inhalation (1725); Chest Pain (1776); Pyrosis/Heartburn (1883); Vomiting (2144)

Event Date 10/20/2014

Event Type  Injury  

Event Description

After having a lap band put in, in (b)(6) 2013, i suffered symptoms including vomiting, aspiration of liquids, heartburn, reflux and chest pain from food getting stuck in my band.I had to have my band removed on (b)(6) 2014.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 4209224
• MDR Text Key: 17274812
• Report Number: MW5038842
• 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: 10/23/2014

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?: Yes
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 159