MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	110-150
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The events of "seroma and capsular contracture" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: seroma and capsular contracture.
Event or Problem Description
Patient reported right side rupture.Healthcare professional reported ¿breast cancer¿, ¿capsular contracture of breast implant¿, ¿slightly increased, small amount of fluid collection around the implant bag¿, ¿prominent internal folding¿.The event of ¿malignant neoplasm¿ is not device related.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening in the shell, underweight, crease flat and wear abrasion.A microscopic analysis was performed which identify a sharp edge opening.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is an opening sharp in the posterior side assessed as unidentified (tear) broken.
Event or Problem Description
Patient reported right side rupture.Healthcare professional reported ¿breast cancer¿, ¿capsular contracture of breast implant¿, ¿slightly increased, small amount of fluid collection around the implant bag¿, ¿prominent internal folding¿.The event of ¿malignant neoplasm¿ is not device related.Device has been explanted.

• Brand Name: STYLE 110 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13309817
• Report Number: 9617229-2021-60241
• Device Sequence Number: 11599770
• Product Code: FTR
• UDI-Device Identifier: 10888628002173
• UDI-Public: 10888628002173
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 01/15/2023
• Device Model Number: 110-150
• Device Catalogue Number: 110-150
• Device Lot Number: 3167370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2018
• 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