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

Catalog Number B-2245

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Vomiting (2144)

Event Date 08/05/2014

Event Type  Injury  

Event Description

Sales rep reported that the lap-band system "buckle of the band" came apart while in the pt.No info was provided on when the event was first noticed.The lap-band system was removed and replaced.Add'l info: the pt called to report "no restriction and pain" with a lap-band system.Follow up findings: pt experienced vomiting prior to having lap-band system replaced.

Manufacturer Narrative

Taper ii.The reporter of the event was asked to return the product for analysis.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Further info from the reporter regarding event, product, or pt details has been requested.No add'l info is available at this time.Pain, vomiting, and band restriction issue is a surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global poark zona franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4101637
• MDR Text Key: 17618998
• Report Number: 2024601-2014-00457
• 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: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2013
• Device Catalogue Number: B-2245
• Device Lot Number: 2077532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 104