MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-20260

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/30/2012

Event Type  Injury  

Event Description

Physician reported patient had intolerance to food.Ten days after implantation, physician unbuckled device.After two months, physician rebuckled device.Three years after device rebuckled, physician removed the complaint device and replaced it with a larger one.

Manufacturer Narrative

(b)(4).Taper ii.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the serial number and implant date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Band restriction issues and intolerance to food are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park zona franca
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78746 ; 8555513123
• MDR Report Key: 4814413
• MDR Text Key: 5893388
• Report Number: 3006722112-2015-00145
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2013
• Device Catalogue Number: B-20260
• Device Lot Number: 2185136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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: NONE PER PHYSICIAN
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 77