MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Device Slipped (1584)

Patient Problems Vomiting (2144); Hernia (2240)

Event Type  Injury  

Event Description

Had lapband placed in 2006.Band slipped, caused hiatal hernia, daily vomiting and esophageal dilation.

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.
• MDR Report Key: 8164374
• MDR Text Key: 130462823
• Report Number: MW5082105
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 109