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

Catalog Number B-2105

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); Regurgitation (2259)

Event Date 07/16/2014

Event Type  Injury  

Event Description

Healthcare professional reported "leaking and a crack in the tubing and the port disconnected from the tubing of a lap-band ap adjustable gastric banding system (standard) port.The event was first noticed when the patient experienced no restriction and could not keep any food down.This event is related to medwatch report# 2024601-2012-00176.

Manufacturer Narrative

Unique identifier (udi)#: not applicable.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 on the 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.

• Brand Name: LAP-BAND SYSTEM ACCESS PORT II KIT
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w. howard lane, ste. 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4381311
• MDR Text Key: 5240131
• Report Number: 2024601-2014-00675
• 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: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-2105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ESTRATEST
• Patient Age: 53 YR
• Patient Weight: 76