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

Catalog Number B-20260

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

Patient Problems Erosion (1750); Fistula (1862)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Reported events of erosion and gastric fistula from journal article: "simultaneous gastric and colonic erosion of gastric band, the american surgeon", january 2014, vol 80.

Manufacturer Narrative

Taper unknown.The reporter of the complaint wa asked to return the product for analysis as well as indicate the product serial number, date of event, implant date and explant date.The product associated with this report has been returned.The connector type cannot be identified nor an assumption made as to the type of connector associated with this complaint because no serial number or implant date was given.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Erosion is a surgical/physiological complication and analysis of device generally does not assist allergan in determining a probably cause for this event.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
• 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: 3645074
• MDR Text Key: 4354967
• Report Number: 2024601-2014-00070
• 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: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2014

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: B-20260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 02/06/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR