MAUDE Adverse Event Report: ALLERGEN LAP BAND; GASTRIC BANDING SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Ulcer (2274)

Event Date 12/24/2012

Event Type  Injury  

Event Description

The allergan lap band has caused a stomach ulcer possible erosion waiting on the device to be removed (b)(6).I was hospitalized (b)(6) 2012 with complications and have been fighting with my insurance to have the product removed.It is painful and had become ineffective finally getting the band removed.The band was implanted in (b)(6) 2007.

• Brand Name: LAP BAND
• Type of Device: GASTRIC BANDING SYSTEM
• Manufacturer (Section D): ALLERGEN
• MDR Report Key: 4190176
• MDR Text Key: 4980312
• Report Number: MW5038678
• 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: 10/14/2014

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 122