MAUDE Adverse Event Report: ALLERGAN LAP-BAND SYSTEM ACCESS PORT II KIT

Catalog Number B-20103

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 04/15/2014

Event Type  Injury  

Event Description

Healthcare professional reported, "having difficulties for a few months - wanting band out.Barium swallow - band tight - total defill.Requesting band out." replacement access port also removed.

Manufacturer Narrative

(b)(4).The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the model number, serial number and implant date provided by the reporter, the connector type associated with this report is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.The reporter of the event was asked to return the product for analysis.Allergan has not received the product at this time.Therefore no analysis or testing has been done.See related medwatch report: 2024601-2013-00063.Band restriction issues and intolerance are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

• Brand Name: LAP-BAND SYSTEM ACCESS PORT II KIT
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park zona franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4101615
• MDR Text Key: 20128573
• Report Number: 2024601-2014-00450
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2014

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: 05/09/2014
• Device Catalogue Number: B-20103
• Device Lot Number: 2286392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Treatment: INSULIN INFUSION PUMP,; RAMIPRIL 5MG OD,; BISOPROLOL; METFORMIN 500MG BID,
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 84