MAUDE Adverse Event Report: ALLERGAN LAP BAND

Device Problem Material Erosion (1214)

Patient Problems Pocket Erosion (2013); Septic Shock (2068)

Event Date 05/01/2016

Event Type  Injury  

Event Description

Five years ago my wife had an allergan lap band inserted into her stomach area by a surgeon contracted out by (b)(6).In (b)(6) 2016, my wife became violently ill and i had to rush her to the emergency room at (b)(6) on (b)(6) 2016.After a ct scan the on-call surgeon noticed my wife's lap band had eroded into her stomach lining and bowel area.Resulting in septic shock and immediate surgery.After surgery, her vitals became alarming and (b)(6) immediately put her on life-support.After the surgery, the surgeon explained to me what happened.He said that the lap band was defected and/or the surgeon who did the installation of lap band may have sutured it to her stomach lining causing erosion and septic shock.After looking at the procedure giving by allergan on a pdf available online, it clearly states that the lap band not be suture to any part of the stomach.My wife almost lost her life and now has permanent bowel problem causing her to miss work and a very uncomfortable feeling on a daily basis.I wish to report this issue to the fda in the concern that it might happen to someone else in the future.I have researched issues with the allergan lap band and i have found there was some misrepresentation on safety procedures.I have hired an attorney and have assembled a team of expert witnesses.I also found that this product has jeopardized several hundred of other people around the country.I beg you to f/u on this soon for the sake of others who have had the allergan lap band procedure.Thanks.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 5825516
• MDR Text Key: 50670512
• Report Number: MW5063660
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/22/2016

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 70