MAUDE Adverse Event Report: ALLERGAN AP SM W/RAPIDPORT EZ

Catalog Number B-20360

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 02/03/2013

Event Type  malfunction  

Event Description

Healthcare professional reported a patient had a lap-band system port explanted and replaced.Follow up findings: healthcare professional reported "loss of restriction and loss of volume from the system.Lack of restriction despite multiple fills." port was explanted and replaced.

Manufacturer Narrative

Unique identifier (udi) #: not applicable.Strain relief.The product associated with this report has not yet been returned.Based upon the catalog number, implant date and identification provided by the reporter the connector type is assumed to be a strain relief.The reporter of the event was asked to return the product for analysis.Visual examination may confirm or determine another 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 information has been reported to allergan regarding serial number or model number.

• Brand Name: AP SM W/RAPIDPORT EZ
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway; global park zona franca; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w. howard lane; suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4381488
• MDR Text Key: 18002029
• Report Number: 2024601-2014-00673
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2014

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 Catalogue Number: B-20360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/31/2014
• 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
• Patient Age: 55 YR
• Patient Weight: 114