MAUDE Adverse Event Report: LAP BAND

Device Problem Material Erosion (1214)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Complaint, Ill-Defined (2331); Depression (2361); Weight Changes (2607)

Event Date 12/10/2015

Event Type  Injury  

Event Description

My body started swelling and building infection.Went to dr and done test and told me i had an erosion (in less than a year of implant) and immediately set the surgery date for next day.After surgery, dr had said that this was the most infection in a body he had ever seen, and if i had waited any longer, it could have been fatal.I was sedated for 4 days i had no idea i was even in there.When i woke up my husband told me we been in there 4 days already.I had 1 iv's running in me as well as a drain tube from my belly.I stayed in there another 4 days before i was able to go home.Since that day i continue to have a lot of stomach pain, stomach issues, depression from this because i felt like a failure, and i am having weight issues again but scared to death to try a different one.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 7112222
• MDR Text Key: 94869720
• Report Number: MW5073949
• 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: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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: 40 YR
• Patient Weight: 125