MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133PLUS FX TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number 133P-FX-16

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem Capsular Contracture (1761)

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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: capsular contracture.

Event Description

Healthcare professional reported capsular contractures baker grade unknown on right side.The device has been explanted.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified: one opening curved on the radius, green mold like appearance, and crease flat.Leak test and microscopic analysis was performed which identified: two openings striated on the radius and anterior.Based on the device analysis the final assessment is: two striated openings due to surgical damage consist in the use of some surgical tool.

Event Description

Capsular contracture was a baker grade iii.The tissue expander was in use for one year.

• Brand Name: STYLE 133PLUS FX TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9454429
• MDR Text Key: 170875476
• Report Number: 9617229-2019-20061
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• PMA/PMN Number: K143354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Catalogue Number: 133P-FX-16
• Device Lot Number: 2935575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention