MAUDE Adverse Event Report: ALLERGAN AP STANDARD RAPID-PORT EZ

Catalog Number B-2360

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problems Nausea (1970); Pain (1994); Regurgitation (2259)

Event Date 12/29/2013

Event Type  Injury  

Event Description

Healthcare professional reported a lap-band for which "a piece of lap band was left in the pt for a period of time when it was removed" and for which there was an unspecified "device defect".Follow-up info: healthcare professional stated the indication of removal was "abdominal pain, nausea, aching, reflux, cramping and intolerance of the lap-band first noticed when the pt visited the physician's office complaining of "significant pain" at the port site.During an "unrelated surgery", after the one performed to remove the entire lap-band system, a foreign object was discovered, which is believed by the physician, to be a part of the lap-band which the hospital referred to as a "strain relief.".

Manufacturer Narrative

Rapidport ez strain relief.The reporter of the complaint was asked to return the product for analysis.The reporter has declined to return the device, but it is in their possession.Based upon the catalog number, serial number and implant date provided by the reporter the connector type is assumed to be a rapidport ez strain relief.Visual examination may determine the connector type associated with this report.

• Brand Name: AP STANDARD RAPID-PORT EZ
• 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 ; 8059615405
• MDR Report Key: 3701747
• MDR Text Key: 16011565
• Report Number: 2024601-2014-00061
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2013
• Device Catalogue Number: B-2360
• Device Lot Number: 2075680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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: MIRAPEX; CELEBREX; VITAMIN D; CELEXA; ZOFRAN; ZANTAC
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 104