MAUDE Adverse Event Report: ALLERGAN, INC. LAP BAND WITH EZ PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

Event Description

This patient had lap band inserted many years ago at another facility and it was removed recently due to stomach erosion.

• Brand Name: LAP BAND WITH EZ PORT
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN, INC.; 12331-a riata trace parkway; building 3; austin TX 78727
• MDR Report Key: 10361662
• MDR Text Key: 201539455
• Report Number: 10361662
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 107