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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Vomiting (2144); Weight Changes (2607); No Code Available (3191)

Event Type  Injury  

Event Description

No exact date.I had a lap band placed, though i lost weight, it was likely due to problems eating with vomiting, caused uncontrollable reflux, esophageal problems, surgically repaired once prior to removal for esophageal issues and reflux.Fda safety report id# (b)(4).

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN / APOLLO ENDOSURGERY INC.
• MDR Report Key: 8683286
• MDR Text Key: 147559197
• Report Number: MW5087212
• 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: 06/05/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 100