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

Catalog Number B-2240

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erosion (1750)

Event Date 05/31/2014

Event Type  Injury  

Event Description

Healthcare professional reported a lap-band system "erosion" first noticed when the pt was presented with "no resistance on the band." the entire lap-band system was removed without replacement.F/u info: device has been explanted.

Manufacturer Narrative

(b)(4).The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the model number, serial number and 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.Erosion 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 AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3975274
• MDR Text Key: 16178196
• Report Number: 2024601-2014-00324
• 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: Physician
• Type of Report: Initial
• Report Date: 06/02/2014

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 Expiration Date: 08/13/2012
• Device Catalogue Number: B-2240
• Device Lot Number: 2003382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• 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
• Patient Age: 48 YR
• Patient Weight: 85