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

Catalog Number B-2260

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

Healthcare professional reported a lap-band system had "greenish fluid coming out of the port" first noticed during a standard adjustment.The device was removed and replaced.

Manufacturer Narrative

Taper ii.Visual examination of the returned device determined the access port tubing connector to be a taper ii.The device was received; however, the device analysis has not been completed.Therefore, the results of the product analysis are not available at this time.Multiple follow up attempts with the surgeon's office have not produced any additional information at this time.Follow up is being continued.Allergan's labeling instructs to inject "sterile, non-pyroganic, saline to irrigate the access port".

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• 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 ; 8059615405
• MDR Report Key: 3753757
• MDR Text Key: 4555048
• Report Number: 2024601-2014-00025
• 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: 01/10/2014

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: 02/11/2013
• Device Catalogue Number: B-2260
• Device Lot Number: 2077538
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2011
• 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 REPORTER.
• Patient Age: 43 YR
• Patient Weight: 67