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

Catalog Number	133MX-15
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2018
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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: adverse reactions deflation- patients should be advised that the tissue expanders may deflate, and require replacement surgery.Deflation occurs when saline leaks through a damaged injection site or a damaged tissue expander envelope.
Event or Problem Description
Healthcare professional reported a right side deflation.Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified fold creases, wear abrasion and brown particles in device inner surface.A leak test was performed which identified no leakage.Based on the device analysis the final assessment is: no openings were found in the device.
Event or Problem Description
Healthcare professional reported a right side deflation.Device has been explanted.

• Brand Name: STYLE 133MX TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7558479
• Report Number: 9617229-2018-03732
• Device Sequence Number: 1818834
• Product Code: LCJ
• UDI-Device Identifier: 10888628004207
• UDI-Public: 10888628004207
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2018

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: 01/23/2021
• Device Catalogue Number: 133MX-15
• Device Lot Number: 3025145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 08/18/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 07/24/2018; 09/13/2018
• 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: 51 YR