MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	68LP-250
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iv.Device has been explanted.Healthcare professional reported treatment with "bra band/massage.".
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The event of "capsular contracture, baker grade iv" 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: capsular contracture, baker grade iv.
Additional Manufacturer Narrative
Device evaluation:visual analysis of the returned device identified: opening and white particle inside device.Leak test was performed and found opening in the anterior.A microscopic analysis was performed which identify opening striated in the anterior.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: a striated opening in the anterior side assessed as surgical damage.Opening.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iv.Device has been explanted.Healthcare professional reported treatment with "bra band/massage.".
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iv.Device has been explanted.Healthcare professional reported treatment with "bra band/massage.".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b3.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iv.Device has been explanted.Healthcare professional reported treatment with "bra band/massage.".

• Brand Name: STYLE 68 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: 14430902
• Report Number: 9617229-2022-08014
• Device Sequence Number: 6428769
• Product Code: FWM
• UDI-Device Identifier: 10888628000568
• UDI-Public: 10888628000568
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/26/2023

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: 03/28/2025
• Device Model Number: 68LP-250
• Device Catalogue Number: 68LP-250
• Device Lot Number: 3515795
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 12/19/2022; 01/09/2023
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/28/2022; 01/04/2023; 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 67 KG