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

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Vomiting (2144); Hernia (2240); Anxiety (2328)

Event Date 10/29/2018

Event Type  Injury  

Event Description

Allergan's lab band installed in 2009.Slipped and caused large hiatal hernia.Vomit multiple times a week, pain, anxiety.

• Brand Name: ALLERGAN'S LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN / APOLLO ENDOSURGERY INC.
• MDR Report Key: 8032593
• MDR Text Key: 126155832
• Report Number: MW5081009
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 91