MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK TISSUE EXPANDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Capsular Contracture (1761)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation was due to capsular contracture, baker grade unknown.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient representative reported event of ¿ductal carcinoma of the breast¿, ¿suffered profound injuries which are permanent and continuing in nature¿, ¿mental and physical pain and suffering, disability and loss of enjoyment of life¿, and ¿severe physical injuries, severe emotional distress, mental anguish¿.Additionally, patient representative reported right side capsular contracture, baker grade not specified.Device was explanted.

• Brand Name: UNK TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• 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: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8932022
• MDR Text Key: 155617181
• Report Number: 9617229-2019-12437
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 36 YR