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

Catalog Number B-2240

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fistula (1862); Vomiting (2144); Hernia (2240); Weight Changes (2607)

Event Date 02/23/2016

Event Type  Injury  

Event Description

Patient brought to operating room for lap band removal due to recent vomiting, feeling fullness in chest and weight gain.Lap band removed by surgeon.Pt also noted to have incisional hernia and gastric fistula.

• Brand Name: ALLERGAN LAP-BAND AP SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; 301 west howard lane suite 100; austin TX 78753
• MDR Report Key: 5466147
• MDR Text Key: 39217957
• Report Number: 5466147
• 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: 02/25/2016

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 Expiration Date: 04/30/2013
• Device Catalogue Number: B-2240
• Device Lot Number: 16635584
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2016
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2016
• 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
• Patient Age: 58 YR