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

Catalog Number	168-360
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/08/2023
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.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 and capsular contracture baker grade unknown.
Event or Problem Description
Healthcare professional reported right side "change in the size of breast," "asymmetry," and "textured implants." healthcare professional additionally reported "hole, non specific," "mazodynia," "capsular contracture baker grade unknown," "possible leakage," and " loose skin involving the circumareolar area." device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ deflation- breast: observed, one opening on posterior side assessed as fold flaw opening.¿ capsular contracture- breast: unable to observe since it is not related to the device.Additional observations: ¿ creases are observed.¿ missing of plug strap assessed as inconclusive.¿ white particles calcification-like were observed on the shell.¿ broken striated on plug strap assessed as surgical damage.¿ yellow particles on device inner surface are observed.No further actions are required since no issue in the manufacturing of the device is observed.
Event or Problem Description
Healthcare professional additionally reported "any creases and particles in valve.".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5.
Event or Problem Description
Healthcare professional later confirmed baker grade iii.

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17388526
• Report Number: 9617229-2023-30956
• Device Sequence Number: 20315632
• Product Code: FWM
• UDI-Device Identifier: 10888628000834
• UDI-Public: 10888628000834
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2023

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: 06/06/2010
• Device Catalogue Number: 168-360
• Device Lot Number: 1298681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/17/2023; 08/28/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/18/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2006
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White