MAUDE Adverse Event Report: LAPBAND

Device Problems Nonstandard Device (1420); Improper or Incorrect Procedure or Method (2017)

Patient Problems Gastritis (1874); Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Date 02/22/2010

Event Type  Injury  

Event Description

I have the 1800 get thin lapband.I have been hell sick everyday of my life now stomach infections.Acid reflux.The pain is unbearable at times it has slipped.Dr put port in wrong and now a recall.I don't even know what to think.A 1800 get thin.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• MDR Report Key: 6427159
• MDR Text Key: 70715745
• Report Number: MW5068575
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 77