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

Catalog Number	133P-FX-14-T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Serious Injury
Additional 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.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 "surgeon punctured implant during surgery." device was not implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: curved opening.A leak test was perform and were found eight openings.A microscopic analysis identified: eight curved striated openings on anterior and posterior side assessed as surgical damage.Based on the device analysis the final assessment is: - curved striated openings assessed as surgical damage.
Event or Problem Description
Company representative reported "surgeon punctured implant during surgery." device was not implanted.

• Brand Name: STYLE 133PLUS FX TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8325538
• Report Number: 9617229-2019-00989
• Device Sequence Number: 10814671
• Product Code: LCJ
• UDI-Device Identifier: 10888628009837
• UDI-Public: 10888628009837
• Combination Product (Y/N): N
• PMA/510(K) Number: K143354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 11/03/2021
• Device Catalogue Number: 133P-FX-14-T
• Device Lot Number: 2993454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/05/2019
• 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; Required Intervention