MAUDE Adverse Event Report: ALLERGAN INC LAP-BAND; IMPLANT, INTRAGASTRIC

Device Problems Migration or Expulsion of Device (1395); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Inflammation (1932)

Event Date 06/29/2014

Event Type  Injury  

Event Description

This is a patient who previously underwent gastric band placement with subsequent revision for prolapse years ago.The patient presented to the emergency room with abdominal pain.Workup ultimately included a ct scan which demonstrated a clear erosion of the band with inflammatory changes around the tubing coursing back to the port.Gastric band noted in the mid stomach and removed in entirety.

• Brand Name: LAP-BAND
• Type of Device: IMPLANT, INTRAGASTRIC
• Manufacturer (Section D): ALLERGAN INC; 71 s los carneros rd; goleta CA 93117
• MDR Report Key: 4027040
• MDR Text Key: 4882084
• Report Number: 4027040
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2014
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 54