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

Catalog Number B-2245

Device Problem Device Slipped (1584)

Patient Problem Not Applicable (3189)

Event Date 07/22/2011

Event Type  Injury  

Event Description

Healthcare professional reported gastric prolapse/band slippage; a lap-band ap system revision surgery, specified as "gastric band unbuckling" took place to treat this event.

Manufacturer Narrative

Taper ii.Medwatch sent to fda on: (b)(4) 2015: the product associated with this report has not yet been returned.Based upon the serial number and implant date provided by the reporter the connector type is assumed to be a taper ii.The reporter of the event was asked to return the product for analysis.Visual examination may confirm or determine another connector type associated with this report.Device labeling addresses the possible outcome of band slippage as follows: band slippage 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 (STANDARD)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: laura leboef ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78746 ; 8555513123
• MDR Report Key: 4911512
• MDR Text Key: 17312459
• Report Number: 3006722112-2015-00199
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2011
• Device Catalogue Number: B-2245
• Device Lot Number: 1774627
• Other Device ID Number: UDI#(01)10811955020190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR