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

Catalog Number	133FX-13
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Company representative reported tissue expander "did not fully deflate but no holes or leaks" prior to insertion, and additionally healthcare professional reported "they actually had to implant it on the right side.¿ device remains implanted.This record is for the right side.
Event or Problem Description
Device has been explanted.

• Brand Name: STYLE 133FX TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8193792
• Report Number: 9617229-2018-09733
• Device Sequence Number: 16648031
• Product Code: LCJ
• UDI-Device Identifier: 10888628004009
• UDI-Public: 10888628004009
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2022
• Device Catalogue Number: 133FX-13
• Device Lot Number: 3207401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other