MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number	SSF-770
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported, left- side "exposed.¿ device has been explanted and replaced.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of exposure 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: exposure.
Event or Problem Description
Healthcare professional reported, left- side "exposed.¿ device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4.
Event or Problem Description
Healthcare professional reported left side "exposed.¿ device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• 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: 16156356
• Report Number: 9617229-2023-00751
• Device Sequence Number: 12192975
• Product Code: FTR
• UDI-Device Identifier: 10888628033252
• UDI-Public: 10888628033252
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: SSF-770
• Device Catalogue Number: SSF-770
• Device Lot Number: 3586948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 01/18/2023; 12/01/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/09/2023; 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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
• Patient Weight: 105 KG