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

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240)

Event Date 01/01/2011

Event Type  Injury  

Event Description

Pt reported that tubing portion of lap-band system adhered to the liver, with scar tissue, there was pain and pt developed a hernia.The lap-band system was not explanted, surgery to correct the "scar tissue" took place.

Manufacturer Narrative

Taper unk.The reporter of the complaint was asked to return the product for analysis if explanted in the future, as well as to indicate the product serial number, implant date, exact date, adn pt info.The info has not yet been received by allergan.The connector type cannot be identified not 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.The reporter of the event was asked to return the product for analysis, if it is explanted in the future.The surgery has not occurred, so allergan has not received the device nor performed analysis at this time.Hernia, adhesion, and pain are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de hereddia ; CS
• Manufacturer (Section G): UNK ALLERGAN; 900 pkwy global park zona franca; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w howard ln; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4380522
• MDR Text Key: 16629315
• Report Number: 2024601-2014-00669
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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 BA
• Was Device Available for Evaluation?: 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention