MAUDE Adverse Event Report: ALLERGAN LAP-BAND SYSTEM ACCESS PORT II KIT; LTI

Catalog Number B-2105

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

Medical health professional reported a lap-band system with "a defective valve".They did not know how the problem was first noticed or what part of the band was affected.All or part of the lap-band was removed; it was unk when the removal surgery took place, what part of the band was removed, or whether the device was replaced.

Manufacturer Narrative

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 and serial number 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.The reporter of the event was asked to return the product for analysis.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Further info from the reporter regarding event, product, or patient details has been requested.No additional info is available at this time.

• Brand Name: LAP-BAND SYSTEM ACCESS PORT II KIT
• Type of Device: LTI
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 pkwy 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: 4134688
• MDR Text Key: 4946308
• Report Number: 2024601-2014-00548
• 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: 09/05/2014

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: 08/22/2015
• Device Catalogue Number: B-2105
• Device Lot Number: 2494777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR