MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

Catalog Number B-2245

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); Weight Changes (2607)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

Healthcare professional reported that "two holes" were found in the tubing of the lap-band system.It was first noticed when the pt was not losing weight.The lap-band port was explanted and replaced.

Manufacturer Narrative

Allergan has received the product however the device has not been identified nor has the analysis has not been completed at this time.Based upon the model number, 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 received the product however the analysis has not been completed at this time.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway gloval park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3888402
• MDR Text Key: 4646916
• Report Number: 2024601-2014-00163
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2014

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 Expiration Date: 10/06/2012
• Device Catalogue Number: B-2245
• Device Lot Number: 2028417
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2010
• 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 Weight: 142