MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MX TISSUE EXPANDER; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number 133MX-13

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted on 10/16/2015.

Event Description

Health professional reported that an "expired" tissue expander was implanted in a patient.No injury to the patient was reported.The device was confirmed to be delivered to the physician's office on (b)(6) 2010 and was implanted on (b)(6) 2015.

• Brand Name: STYLE 133MX TISSUE EXPANDER
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: krista alvarado ; 301 w howard lane; suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 5157276
• MDR Text Key: 28566304
• Report Number: 9617229-2015-00438
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Catalogue Number: 133MX-13
• Device Lot Number: 1841700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2010
• 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): Other