MAUDE Adverse Event Report: ALLERGAN; IMPLANT, INTRAGASTRIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Dysphagia/ Odynophagia (1815); Obstruction/Occlusion (2422); Obstruction/Occlusion (2422)

Event Date 11/21/2014

Event Type  Injury  

Event Description

Gastric band prolapse: a patient who previously undergone gastric band placement, began to develop obstructive symptoms of dysphagia and reflux.The workup included an upper gi which demonstrated esophageal dilation.The patient required removal of the gastric lap band device given these findings.

• Type of Device: IMPLANT, INTRAGASTRIC
• Manufacturer (Section D): ALLERGAN; 71s los carneros rd; goleta CA 93117
• MDR Report Key: 4377156
• MDR Text Key: 5288640
• Report Number: 4377156
• 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: 11/25/2014

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO KNOWN OTHER DEVICES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 126