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

Model Number	SCX-420
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930)
Date of Event	10/18/2020
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.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: rupture and capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional reported right side "rupture and a capsular contracture, baker grade iii".Device remains implanted.
Event or Problem Description
Healthcare professional additionally reported "probable infection" and "purulent type, thickened milky fluid expressed from the right breast prepectoral space." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: creases fold, deformation, cloudy in the gel and the weight the device within specification.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h6.A review of the device history record/further investigation has been completed for infection late onset.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional reported right side "capsular contracture," baker grade iii.Healthcare professional additionally reported "probable infection" and "purulent type, thickened milky fluid expressed from the right breast prefectorial space." device has been explanted.

• Brand Name: INSPIRA SMOOTH COHESIVE 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; CS
• MDR Report Key: 11008632
• Report Number: 9617229-2020-20679
• Device Sequence Number: 11861159
• Product Code: FTR
• UDI-Device Identifier: 10888628030305
• UDI-Public: 10888628030305
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2021

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: 09/06/2023
• Device Model Number: SCX-420
• Device Catalogue Number: SCX-420
• Device Lot Number: 3261273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/22/2020; 05/10/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 04/15/2021; 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR