MAUDE Adverse Event Report: LAPBAND 10 CM

Device Problem Device Slipped (1584)

Patient Problems Autoimmune Disorder (1732); Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

I had lapband surgery (b)(6) 2004.I was diagnosed with autoimmune type i diabetes and hashimotos disease in 2010.Symptoms of the diabetes started in 2008.I truly believe that the autoimmune disease was related to the lapband.Initial lapband lagb 10 cm (b)(4).This band slipped severely with significant adhesions in 2006 resulting in removal with a new lap band inserted later that same year.The new unit was a lagb 10 cm s/n (b)(4).I had this unit removed (b)(6) 2012.

• Brand Name: LAPBAND 10 CM
• Type of Device: LAPBAND 10 CM
• MDR Report Key: 5616486
• MDR Text Key: 43995262
• Report Number: MW5061963
• Device Sequence Number: 2
• Product Code: LTI
• 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: 04/23/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 73