MAUDE Adverse Event Report: ETHICON ENDO-SURGERY INC. REALIZE LAP BAND; IMPLANT, INTRAGASTIC FOR MORBID OBESITY

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 11/01/2015

Event Type  Injury  

Event Description

My lap band eroded into my stomach two inches.It was removed by dr (b)(6).I got the lap band placed in (b)(6) 2009.I did lose weight but in (b)(6) 2015 i was in a great deal of pain and always sick.I had an upper gi and that is my dr saw a two inch in my stomach were the band had eroded into my stomach.Once my insurance approved the removal i had it removed.I was in the hosp overnight and recovering was awful.

• Brand Name: REALIZE LAP BAND
• Type of Device: IMPLANT, INTRAGASTIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.
• MDR Report Key: 8278044
• MDR Text Key: 134438209
• Report Number: MW5083396
• 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: 01/23/2019

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: 01/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 108