MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	168-330
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
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.Reason for reoperation: deflation.
Event or Problem Description
Patient reported right side deflation and removal from textured to smooth due to the concerns of the product.Later healthcare professional confirmed deflation and removal from textured to smooth due to the concerns of the product.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation.Based on the device analysis grid, the assessments of the complaint are: ¿ deflation: observed 1 opening assessed as fold flow opening.¿ anxiety product/procedure: unable to observe as it is not related to the device.Additional observations: ¿ creases were observed.¿ wear abrasion observed.¿ yellow particles observed the outside of the device.
Event or Problem Description
Patient reported right side deflation and removal from textured to smooth due to the concerns of the product.Later healthcare professional confirmed deflation and removal from textured to smooth due to the concerns of the product.Device has been explanted.
Event or Problem Description
Device has been explanted.

• Brand Name: STYLE 168 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17686256
• Report Number: 9617229-2023-14349
• Device Sequence Number: 11408805
• Product Code: FWM
• UDI-Device Identifier: 10888628000827
• UDI-Public: 10888628000827
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2023

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: 06/12/2020
• Device Catalogue Number: 168-330
• Device Lot Number: 2935652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/10/2023; 11/17/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/31/2023; 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG