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 Patient Problem/Medical Problem (2688)

Event Date 02/15/2015

Event Type  malfunction  

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.

Event Description

Physician reported that device was enlarged with air and contaminated with fungus.Accompanying diagram shows device filled with equal portions of liquid and air.Device was removed and not replaced.Additional information: physician reported "slight densification of fat planes in omentum region, possibly due to compressive effect or inflammatory alteration.".

• 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: 5058417
• MDR Text Key: 25116016
• Report Number: 3006722112-2015-00342
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020541
• UDI-Public: (01)10811955020541(10)2673531(11)141119(17)161119
• 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
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-50000
• Device Lot Number: 2673531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2014
• 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 Age: 54 YR
• Patient Weight: 83