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 07/04/2015

Event Type  Injury  

Manufacturer Narrative

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.No additional information has been reported to allergan regarding patient data or further event details.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.

Event Description

Healthcare professional reported abdominal x-ray "showed air hyperinsuflation in the balloon and patient with intense abdominal pain".The device was explanted without replacement.

Manufacturer Narrative

(b)(4).

Event Description

Healthcare professional reported abdominal x-ray "showed air hyperinsuflation in the balloon and patient with intense abdominal pain." the device was explanted without replacement.

• 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: 5077914
• MDR Text Key: 25821046
• Report Number: 3006722112-2015-00368
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020541
• UDI-Public: (01)10811955020541(10)2690095(11)150107(17)170107
• 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: 08/26/2015

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: 01/07/2017
• Device Catalogue Number: B-50000
• Device Lot Number: 2690095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2015
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2015
• 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): Other; Required Intervention
• Patient Age: 53 YR