MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 10 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	10-420
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported a buckle/ripple/fold that they can see and feel.Healthcare professional reported a right side capsular contracture baker grade iv, visual distortion, and pain.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: capsular contracture baker grade iv.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4.
Event or Problem Description
Patient reported a buckle/ripple/fold that they can see and feel.Healthcare professional reported a right side capsular contracture baker grade iv, visual distortion, and pain.Device has been explanted.
Event or Problem Description
Patient reported a buckle/ripple/fold that they can see and feel.Healthcare professional reported a right side capsular contracture baker grade iv, visual distortion, and pain.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: crease/folding of implant observed creases fold on the device.Capsular contracture: unable to observe since it is a medical event and is not related to the device.Wrinkling is observed in the device.Pain: unable to observe since it is a medical event and is not related to the device.Visibility/palpability: unable to observe since it is a medical event and is not related to the device.Additional observations: crease fold observed on the device.Wear abrasion observed on the device.Additional, changed, and/or corrected data.

• Brand Name: STYLE 10 SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 12855570
• Report Number: 9617229-2021-57384
• Device Sequence Number: 12050972
• Product Code: FTR
• UDI-Device Identifier: 10888628001282
• UDI-Public: 10888628001282
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2022

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: 06/15/2020
• Device Model Number: 10-420
• Device Catalogue Number: 10-420
• Device Lot Number: 2777005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/14/2022; 10/07/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/14/2022; 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2015
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 66 KG