MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

Catalog Number AB-20260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Seroma (2069); Fluid Discharge (2686)

Event Date 04/23/2014

Event Type  Injury  

Event Description

Healthcare professional reported, "port site infection - gp started oral ab.F/u [surgeon] - cellulitis over port, discharging seroma.Admitted to [hospital] [five days] for iv antibiotics".Final diagnosis - "wound infection - ongoing review".

Manufacturer Narrative

The product associated with this report has not been returned as the device was not explanted.Based upon the model number, serial number and implant date provided by the reporter the connector type is assumed to be a taper ii.The reporter of the event was asked to return the product for analysis, if it is explanted in the future.The pt has been treated with antibiotics and the device remains implanted, so allergan has not received the device nor performed analysis at this time.Cellulitis, infection, seroma and drainage are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional info has been reported to allergan regarding the diagnostic testing, pt data or further event details.Device labeling addresses the possible outcome of an infection as follows: "infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated".Device labeling addresses the reported event of seroma, cellulitis and drainage as follows: "it is important to discuss all possible complications and adverse events with your pt.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the pt's degree of intolerance to any foreign object implanted in the body".

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park zone franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3839259
• MDR Text Key: 15820087
• Report Number: 2024601-2014-00266
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2015
• Device Catalogue Number: AB-20260
• Device Lot Number: 2533194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR