MAUDE Adverse Event Report: ALLERGAN/APOLLO LAPBAND

Device Problem Device Slipped (1584)

Patient Problems Vomiting (2144); Obstruction/Occlusion (2422); Choking (2464); Abdominal Cramps (2543)

Event Date 10/01/2010

Event Type  Injury  

Event Description

I had the allergan lap band device put in 2008.Dr (b)(6) did the surgery.I was admitted back in hospital 2 days after i went home for severe stomach cramps.I had an abstruction.I had an ng tube stuck in my nose for 2 days, couldn't eat or drink.I was on oxygen for 2 days.Also in (b)(6) 2010 i started throwing up every time i ate.I went back to my surgeon.He said my band had slipped, they had to take all fluid out of band.I no longer had insurance so my surgeon said it was gonna cost (b)(6) to get it removed.I couldn't afford it so i had to suffer with the throwing up after every meal.The only thing i could eat without getting sick was popcorn and salad.I finally was able to get insurance in 2013 and in (b)(6) of that year i had my lap band removed.I found out that band slippage was common.I live in a small town or around 13000 people know of 4 others in my home town that had the same problem and had to have their's removed.It was awful getting sick so much sometimes it was so hard i almost choked.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• Manufacturer (Section D): ALLERGAN/APOLLO
• MDR Report Key: 6529515
• MDR Text Key: 74088211
• Report Number: MW5069390
• Device Sequence Number: 1
• 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: 04/27/2017

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CYCLOBENZAPRINE; ENALAPRIL; GABAPENTIN.; OTC MEDS: MULTI VITAMIN.; PRAVASTATIN; RX MEDS: TRAMADOL
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 107