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

Catalog Number	133FX-15-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Additional 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 anterior.Leak test and microscopic analysis was performed which identified: one opening sharp on the anterior and broken striated on the suture tab (partial separation).Based on the device analysis the final assessment is: a striated broken on the suture tab (partial separation) due to surgical damage consist in the use of some surgical tool.One sharp opening due to an unidentified (tear) opening.The reason for reoperation: deflation.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
Healthcare professional reported right side deflation of a tissue expander.Device has been removed and replaced with another expander.

• Brand Name: STYLE 133FX 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: 8800695
• Report Number: 9617229-2019-08569
• Device Sequence Number: 3294773
• Product Code: LCJ
• UDI-Device Identifier: 10888628004320
• UDI-Public: 10888628004320
• Combination Product (Y/N): N
• Initial Reporter State: MT
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: 133FX-15-T
• Device Lot Number: 3169313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/17/2019
• 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: Required Intervention
• Patient Age: 43 YR