MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

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

Patient Problems Abscess (1690); Erosion (1750); Gangrene (1873); Unspecified Infection (1930); Nausea (1970); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Sepsis (2067)

Event Date 04/03/2012

Event Type  Injury  

Event Description

Patient's attorney reported, "[patient] began experiencing severe stomach ailments" and was "admitted to the emergency room." patient was "complaining of persistent nausea and abdominal pain for the previous few days and further complaining that the pain was getting progressively worse." during [patient's] admission.Pain acutely worsened, thereby requiring an endoscopy." "that endoscopy revealed that the allergan lap-band that had been implanted in [patient] was eroded to the lumen of the stomach.As a result, [patient] was suffering from life threatening abdominal sepsis and a gangrenous stomach, as well as perforated viscus, thereby requiring an emergency laparotomy." "the [patient] subsequently had to undergo revision of the laparotomy due to surgical wound abscess." ".[patient required the assistance of a ventilator, almost perished, and, for a significant period of time thereafter, [patient] could only be nourished via a feeding tube." "because of the severity of the medical ailments caused by the lap-band erosion, in the several months following the surgeries.[patient] was admitted.On multiple occasions requiring additional operative procedures involving extended hospital stays." "[patient] has sustained severe and permanent injuries as a result.That have caused [the patient] continuous pain and suffering, have prevented [the patient] from working.Have limited [patient's] movements, have caused significant limitations and discomfort, and have prevented [patient] from undertaking or participating in [their] normal and regular activities.

Manufacturer Narrative

Taper unknown.The product associated with this report has not been returned for analysis.The reporter did not indicate the product serial number or catalog number.Based upon the implant date provided by the reporter, the connector type is either a taper i or taper ii.Visual examination may determine the connector type associated with this report.The reported adverse events 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 to allergan regarding the serial number or catalog number.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3701214
• MDR Text Key: 4263446
• Report Number: 2024601-2014-00082
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P0000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/29/2014

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: LAP-BAND ADJUSTABLE GASTRIC BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/19/2014
• 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; Life Threatening; Disability