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

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

Patient reported "clasp on my band is broken, it is now 'c' shaped and i have no restriction at all." it is not known if explant surgery has taken place.The reported event has currently not been confirmed by a healthcare professional.

Manufacturer Narrative

Unique identifier (udi)#: not applicable.Taper unknown.The reporter of the complaint was asked to return the product for analysis was well as to indicate the product serial number, date of event, implant date and explant date.The information has not yet been received by allergan.The connector type cannot be identified nor an assumption be made as to the type of connector associated with this complaint because no serial number or implant date was given.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.Device labeling addresses the possible outcome of an unbuckled band as follows:.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway golbal park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 11009 metric blvd j100; austin, TX 78758-5506 ; 5128132638
• MDR Report Key: 4316617
• MDR Text Key: 5211894
• Report Number: 2024601-2014-00627
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 11/04/2014
• 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