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

Catalog Number B-2240

Device Problem Fluid/Blood Leak (1250)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Bacterial Infection (1735); Erosion (1750); Chest Pain (1776); Purulent Discharge (1812); Fever (1858); Failure of Implant (1924); Inflammation (1932)

Event Date 02/15/2014

Event Type  Injury  

Event Description

Patient reported "erosion" of the stomach and infection after implant with the lap-band system.Follow-up findings: healthcare professional reported patient complained of "significant pain, chills", "high fever and abscess near the wound site and abdomen", gastritis, left chest pain under left rib that gets worse after eating, coughing and sneezing, and "no restriction".Patient was hospitalized and diagnostic imaging showed "fluid collection and infection at band site"."port site incision had opened up", granulation tissue over the port site, about 2 cm in length", flu-like symptoms, tenderness in lower left quadrant", skin had dehisced, port was not exposed" and "incision still draining", and "soaks gauze with pus".The port and entire band were removed; operative report indicated "chronic inflammation around the tubing and significant inflammation around the band" and "chronic infection and purulent material around lap band subcutaneous port.Chronic inflamed tissue was excised".

Manufacturer Narrative

(b)(4).Taper ii.Medwatch sent to fda on 03/31/2015.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 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.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Infection, gastric erosion, gastritis, pain, fever, flu-like symptoms, abscess, drainage, inflammation, wound dehiscence, and delayed healing 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 AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78746-0000 ; 8555513123
• MDR Report Key: 4651900
• MDR Text Key: 5759160
• Report Number: 3006722112-2015-00103
• 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,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/04/2015

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-2240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 03/31/2015
• 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
• Treatment: CINGULAIR; ADVAIR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 266 YR