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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vomiting (2144); Premature Labor (2465); Weight Changes (2607); Unspecified Tissue Injury (4559)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Lapband placed in 2006.I had to have it removed in 2021, due to severe gerd and esophagus mobility issues.I threw up almost everything i ate and this caused damage to my esophagus.Band became very tight during pregnancy and i lost weight during the pregnancy.Baby was born (b)(6) early and (b)(6).Fda safety report id# (b)(4).

• Brand Name: LAPBAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN / APOLLO ENDOSURGERY INC.
• MDR Report Key: 13590666
• MDR Text Key: 286050612
• Report Number: MW5107642
• 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: 02/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ANTACID; MULTIVITAMIN
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White