MAUDE Adverse Event Report: INAMED/ALLERGAN/ APPLO EDOSURGERY LAP-BAND

Device Problem Insufficient Information (3190)

Patient Problems Dehydration (1807); Gastritis (1874); Swelling (2091); Vomiting (2144); Ulcer (2274)

Event Date 06/15/2014

Event Type  Injury  

Event Description

Lap-band failed.Had to be removed.Constant vomiting.Gastritis.Almost dehydrated to death from swollen esophageal ulcers at band site.

• Brand Name: LAP-BAND
• Type of Device: LAP-BAND
• Manufacturer (Section D): INAMED/ALLERGAN/ APPLO EDOSURGERY
• MDR Report Key: 6584681
• MDR Text Key: 75855360
• Report Number: MW5069927
• Device Sequence Number: 0
• Product Code: LTI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 31 YR
• Patient Weight: 68