MAUDE Adverse Event Report: ALLERGAN LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number 3360-02

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Date 12/10/2015

Event Type  malfunction  

Event Description

Female patient had lap band implanted approx 8 years ago with a revision/ replacement of port a couple of years ago and also in (b)(6) of last year for repair of tubing.Patient continued to have issues with device and opted to have it removed earlier this year.Patient began having abd pains after explant of lap band and was noted by ct to have possible retained foreign object so returned to surgery this month for explant of retained tubing.

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; 2525 dupont dr.; irvine, CA 92612
• MDR Report Key: 5322166
• MDR Text Key: 34205833
• Report Number: 5322166
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3360-02
• Device Lot Number: 37KJ1503
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2015
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2015
• 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
• Patient Age: 47 YR
• Patient Weight: 88