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

Catalog Number LAP-BAND ADJUSTABL GASTRIC BAN

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

Patient Problems Nausea (1970); Vomiting (2144); Weight Changes (2607)

Event Date 05/18/2015

Event Type  Injury  

Event Description

Healthcare professional reported lap-band system and port removal due to nausea and vomiting.The patient did not experience significant weight loss and the patient requested removal of the device.

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 implant date and explant 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.Vomiting, nausea and unsatisfactory weight loss re surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probably cause for these vents.No additional information has been reported to allergan regarding the serial number, catalog number, event date or patient data.Device labeling addresses the possible outcomes of nausea, vomiting, and inadequate weight loss as follows: caution: insufficient weight loss may be a symptom of inadequate restriction; (band too loose).Of, it may be a symptom of pouch or esophageal enlargement, and may be accompanied by other symptoms, such as heartburn, regurgitation or vomiting.If this is the case, inflation of the band would not be appropriate.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 global park zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4864912
• MDR Text Key: 17215798
• Report Number: 3006722112-2015-00195
• 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: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2015

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: LAP-BAND ADJUSTABL GASTRIC BAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/22/2015
• 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: "ON VARIOUS MEDICATIONS" PER PHYSICIAN
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 100