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

Model Number B2365

Device Problem Migration (4003)

Patient Problems Erosion (1750); Failure of Implant (1924)

Event Date 07/11/2022

Event Type  Injury  

Event Description

In 2013, i had lap band surgery done over gastric bypass.I haven't felt good for a couple years and out of desperation went back to my bariatric doctor, who noticed the band had eroded into my stomach.I've had three surgeries so far because the band didn't just rolled into my stomach, but also into my intestines.I still have to have one more surgery.The manufacture of my lap band was allergan.

• Brand Name: LAP BAND AP WITH RAPID PORT EZ
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN /APOLLO ENDOSURGERY INC.
• MDR Report Key: 16043352
• MDR Text Key: 306207091
• Report Number: MW5113968
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B2365
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White