MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) ORBERA INTRAGASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-50000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abdominal Pain (1685)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on: 09/14/2015.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Pain is a surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device labeling addresses the reported event of pain as follows: possible complications of the use of the orbera system include: abdominal or back pain, either steady or cyclic.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.

Event Description

Healthcare professional reported patient was hospitalized with "intense abdominal pain", "suspect of acute abdomen".Diagnostic testing showed "abdominal distension, balloon with twice the size [with lot of air inside]." the device was explanted and the patient was treated with morphine for the pain.

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; bulding 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 5074296
• MDR Text Key: 25650994
• Report Number: 3006722112-2015-00355
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020541
• UDI-Public: (01)10811955020541(10)2690134(11)150119(17)170119
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2017
• Device Catalogue Number: B-50000
• Device Lot Number: 2690134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2015
• Initial Date FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 90