LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Report

Report Number: 2024601-2008-00854
Event Type: Injury
Date Received: November 12, 2008
Date of Event: September 15, 2004
Report Date: October 14, 2008
Manufacturer: COSTA RICA
Product Code: LTI
PMA / PMN Number: P000008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFORMATION HAS NOT BEEN RECEIVED BY ALLERGAN. BASED ON THE PROBABLE IMPLANT DATE, THE TAPER 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. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. VOMIT IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED."

Description of Event or Problem · 1

REPORTED EVENT OF READMISSION TO THE HOSPITAL, DUE TO VOMITING FROM JOURNAL ARTICLE "ONE-YEAR READMISSION RATES AT A SURGERY CENTER: LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING, LAPAROSCOPIC GASTRIC BYPASS, AND VERTICAL BANDED GASTROPLASTY-ROUX-EN-Y GASTRIC BYPASS", J. SAUNDERS, ET AL (2008) OBES SURG 18:1233-1240 SPRINGER SCIENCE. ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	DEVICE FOR TREATMENT OF MORBID OBESITY	LTI	COSTA RICA	N/A	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI		Hospitalization\| R