MAUDE Adverse Event Report: LAP BAND

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Vomiting (2144)

Event Type  Injury  

Event Description

Lap band placed 2010 approx.Constant vomiting and nausea.Had to be removed to prevent further health problems.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 6129031
• MDR Text Key: 61015907
• Report Number: MW5066358
• 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: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B12; CALCIUM; IRON; OTC MEDS: DAILY MTV; RX MEDS: NONE.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 110