MAUDE Adverse Event Report: ALLERGAN/APOLLO ENDOSCOPY INC. ALLERGAN GASTRIC LAP-BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Vomiting (2144); Weight Changes (2607); No Code Available (3191)

Event Date 03/19/2019

Event Type  Injury  

Event Description

The problem has been on going with my lap band after it slipped in (b)(6) of 2015.I just had my band removed on (b)(6) 2019 due to numerous health complications.My esophagus is dilated and hopefully will go back to normal, or i may have to have more surgery to fix that.The first few years of my band were great, but then something happens inside and everything swells up and it is never right again.I had shoulder pain, constant pain in my port site, which had been replaced and moved a few times while i had the band.For weeks i would be fine, and then all of the sudden, my band would tighten and i would not be able to even keep water down.I did lose weight with it, it was a lifesaver in many ways, but it has also caused so much suffering as well.I was told that slippage was less than 1% of people, i have heard of so many who had major slippage of their brand.I feel if i continued to have it in me, i would be dead from it in the next few years.I have a long road to true recovery ahead of me.I also have extreme gerd since having the band.

• Brand Name: ALLERGAN GASTRIC LAP-BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN/APOLLO ENDOSCOPY INC.
• MDR Report Key: 8456824
• MDR Text Key: 140265089
• Report Number: MW5085213
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2019
• 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: 47 YR
• Patient Weight: 118