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 06/15/2014

Event Type  malfunction  

Event Description

Physician reported filling the band was fine but when checking the band was found to have the buckle detached.

Manufacturer Narrative

Unique identifier (udi)#: na.Taper unk.The access port associated with this report was not returned as the access port was not explanted and returned with the three tubing pieces.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.The reporter of the complaint was asked to indicate the product serial number, date of event, implant date and pt data.The info has not yet been received by allergan.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): UNK ALLERGAN; 900 pkwy global park zona franca; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w howard ln; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4352908
• MDR Text Key: 5220796
• Report Number: 2024601-2014-00681
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• 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?: Yes
• Date Manufacturer Received: 12/03/2014
• 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
• Patient Age: 43 YR