MAUDE Adverse Event Report: ALLERGAN LAP BAND

Device Problems Break (1069); Material Erosion (1214)

Patient Problems High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Palpitations (2467)

Event Date 02/10/2016

Event Type  Injury  

Event Description

After having the lap band for 8 years, the port broke through the skin and caused an infection.I had to have surgery to remove the band and drains inserted to remove any additional infection.I was also on medication for pain and the infection.Additionally as the band eroded i developed heart palpitations and elevated blood pressure associated with the erosion.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 5546929
• MDR Text Key: 41940564
• Report Number: MW5061469
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 109