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

Catalog Number B-50000

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

Patient Problems Inflammation (1932); Pain (1994); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on: 10/20/2015.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.Inflammation, pain and malaise are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the serial number, the event date, treatment date, explant date, diagnostic testing, patient data or further event details.Device labeling addresses the reported event of inflammation/irritation as follows: contraindications for the use of the orbera¿ system include: any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as crohn¿s disease.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.Device labeling addresses the reported event of malaise as follows: the physiological response of the patient to the presence of the orbera¿ system balloon may vary depending upon the patient¿s general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.

Event Description

Patient reported experiencing "gastritis" and "back pain" "medication" used to treat these events.Patient also reports "discomfort while sleeping", and "weakness because of alimentary restriction and caloric reduction" and unsatisfactory weight loss.Device remains implanted.

• 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; building 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 5162721
• MDR Text Key: 28798176
• Report Number: 3006722112-2015-00475
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Report Date: 09/30/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: B-50000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OMZ,PAN,DOMPERIDON,GAVISCON
• Patient Outcome(s): Required Intervention