MAUDE Adverse Event Report: ALLERGAN LAP-BAND

Model Number B-2245

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Internal Organ Perforation (1987)

Event Date 09/25/2012

Event Type  Injury  

Event Description

I had the allergen lap-band put in (b)(6) 2008.After having problems with my stomach, my dr.Had a egd done on (b)(6) 2012.The egd show that the lap-band had caused erosion and caused a hole in my stomach.After that i still have not recovered fully.Dates of use: (b)(6) 2008 - (b)(6) 2012.Diagnosis or reason for use: to lose weight so my back would hurt less.

• Brand Name: LAP-BAND
• Type of Device: LAP-BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 4426176
• MDR Text Key: 5414016
• Report Number: MW5040223
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B-2245
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 115