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

Catalog Number AB-20260

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

Pt reported "unclipped band".

Manufacturer Narrative

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 model number, serial number and partial 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.No additional info has been reported to allergan regarding the event date, full implant date, full explant date, diagnostic testing, and the events have not been confirmed by a physician.Device labeling addresses the possible outcome of an unbuckled band as follows: warning: "failure to secure the band properly may result in it subsequent displacement and necessitate re-operation".Caution: "failure to use an appropriate atraumatic instrument such as the lap-band system closure tool to lock the band may result in damage to the band or injury to surrounding tissues"."the mfr of the lap-band ap adjustable gastric banding system has designed, tested and mfr it to be reasonably fit for its intended use.However, the lap-band ap system is not a lifetime product and it may break of fail, in whole or in part, at any time after implantation and not with standing the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component failure and normal wear and tear.In addition, the lap-band ap system may be easily damaged by improper handling or use".

Manufacturer Narrative

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA ; 900 parkway global park ; zona franca ; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4239201
• MDR Text Key: 4988100
• Report Number: 2024601-2014-00596
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020008
• UDI-Public: (01)10811955020008
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,company representati
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2015
• Device Catalogue Number: AB-20260
• Device Lot Number: 2401700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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