MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

Catalog Number LAP-BAND ADJUSTABLE GASTRIC

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2008

Event Type  Injury  

Event Description

Patient reported that band portion of the lap-band system slipped.The "band portion" was replaced but the tubing and port were not replaced.

Manufacturer Narrative

The reporter of the complaint was asked to return the product for analysis as well as to indicate the product serial number, date of event, implant date and explant date.The information has not yet been received by allergan.The connector type cannot be identified nor an assumption be made as to the type of connector associated with this complaint because no serial number or implant date was given.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.Band slippage is a surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN; 900 parkway global zona franca; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w. howard lane, ste. 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4379968
• MDR Text Key: 16628808
• Report Number: 2024601-2014-00668
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/03/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: LAP-BAND ADJUSTABLE GASTRIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/24/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention