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

Catalog Number B-2240

Device Problems Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Seroma (2069); Fluid Discharge (2686)

Event Date 02/15/2008

Event Type  Injury  

Event Description

Patient reported a lap-band with a leaking port for which the patient experienced "multiple infections" , first noticed when "there was a big water pocket that came up like there was a basketball on my stomach, it busted and ran fluid on the outside instead of on the inside." the patient also stated that after the port was removed, the tubing "attached itself" to the tissue and "created infection." the lap-band port was removed without replacement on one date, and the remainder of the lap-band system was removed without replacement on a later date.The events have not yet been confirmed with a medical healthcare professional.

Manufacturer Narrative

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.The reporter of the event was asked to return the product for analysis.Allergan has not received the product at this time.Therefore, no analysis or testing has been done.Infection, seroma, adhesion and drainage are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported allergan regarding the serial number, the full event date, further event details or confirmation by a medical professional.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• 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 ; 8059615867
• MDR Report Key: 4193431
• MDR Text Key: 4967098
• Report Number: 2024601-2014-00577
• 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: 09/22/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2010
• Device Catalogue Number: B-2240
• Device Lot Number: 1541269
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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
• Treatment: XANAX
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR