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

Catalog Number B-2240

Device Problem Device Slipped (1584)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Contusion (1787); Dehydration (1807); Pyrosis/Heartburn (1883); Inflammation (1932); Nausea (1970); Vomiting (2144); Regurgitation (2259); Weight Changes (2607)

Event Date 11/05/2009

Event Type  Injury  

Event Description

Pt reported lap-band "prolapsed and caused bruised and scarred stomach tissue." the event was first noticed with symptoms of dehydration and gastric distress.The lap-band was explanted.Additional findings: healthcare professional reported over a series of office visits the lap-band was unfilled and later saline was slowly added.Pt complained of "vomiting (emesis), reflux, band too tight, burning after eating, belching regurgitation, unable to drink, not tolerating many foods, dysphagia, night cough, and gerd." then during unfilled period complained of "hungry all the time," "eating large portions," "feels no restriction" and "weight gain." pt was hospitalized for "severe intractable nausea, vomiting with inability to keep anything down, and right upper quadrant pain." pt had "episode of gastritis," "partial band slip," and "esophagitis." pt opted to "keep the band in place without any fill.".

Manufacturer Narrative

(b)(4).Taper ii.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 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.Allergan has not received the product at this time.Therefore, no analysis or testing has been done.Vomiting, dehydration, contusion, inflammation/irritation, food intolerance, abdominal pain, dysphagia, band slippage, cough, reflux, adhesions, heartburn, nausea and unsatisfactory weight loss 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 (Section G): COSTA RICA; 900 pkwy global park zona franca
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78746 ; 8555513123
• MDR Report Key: 4846648
• MDR Text Key: 5873489
• Report Number: 3006722112-2015-00153
• 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: Other,Consumer,Health Professional
• Type of Report: Initial
• Report Date: 05/18/2015

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 Expiration Date: 05/28/2011
• Device Catalogue Number: B-2240
• Device Lot Number: 1731251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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: EFFEXOR; LANSOPRAZOLE; METFORMIN; SERTRALINE; ECOTRIN; MULTIVITAMINS; METROPROLOL TARTRATE; HYDROCHLOROTHIAZIDE; ADVIL; TRAMADOL; ATROVASTATIN CALCIUM; NYSTATIN; ANASTROZOLE; SYNTHROID; LOSARTAN POTASSIUM; IRBESARTAN; BUPROPION; SIMVASTATIN; CELEBREX; LOPRESSOR; AVAPRO
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 122