MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	468-380
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2021
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: fold creases.Leak test and microscopic analysis was performed which identified: the unit does not leak.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.No deformity was observed.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
Healthcare professional reported a left side breast deformity, pain in the breasts, and a baker grade ii capsular contracture in addition to possible leaking of the mammary implants suspected due to the change in size of the implants.Device has been explanted and replaced.
Additional Manufacturer Narrative
Correction for device evaluation: based on the device analysis grid, the assessments of the complaint are: fluid leak: not observed.Breast pain: unable to observe as it is a medical event that is not related to the device.Capsular contracture: unable to observe as it is a medical event that is not related to the device.Deformity/ disfigurement: unable to observe as it is a medical event that is not related to the device.Additional observations: crease fold is observed.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare professional reported a left side breast deformity, pain in the breasts, and a baker grade ii capsular contracture in addition to possible leaking of the mammary implants suspected due to the change in size of the implants.Device has been explanted and replaced.

• Brand Name: STYLE 468 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: 16194286
• Report Number: 9617229-2023-30164
• Device Sequence Number: 14968891
• Product Code: FWM
• UDI-Device Identifier: 10888628001138
• UDI-Public: 10888628001138
• 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: 2002
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 05/25/2006
• Device Model Number: 468-380
• Device Catalogue Number: 468-380
• Device Lot Number: 577602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2002
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White