MAUDE Adverse Event Report: ALLERGAN, INC. LAP-BAND AP; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-2240

Device Problem Material Integrity Problem (2978)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/07/2016

Event Type  malfunction  

Event Description

Gastric band originally implanted 9 years ago for patient's morbid obesity.According to the op report, "the band appears to be having a significant fibrosis makes it a nonadjustable band, is acting like a rigid obstruction on the gastric pouch grade in the proximal dilation aspiration events.Since nonoperative management has failed, patient has had progressive symptoms, i feel it is necessary that she undergo urgent removal of the laparoscopic adjustable band and port.".

• Brand Name: LAP-BAND AP
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN, INC.; 2525 dupont dr.; irvine CA 92612
• MDR Report Key: 6228474
• MDR Text Key: 64055154
• Report Number: 6228474
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: B-2240
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2016
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 62 YR
• Patient Weight: 68