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-525
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The events of exposure and infection (late onset) 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: exposure and infection (late onset).
Event or Problem Description
Healthcare professional reported right side exposure and infection.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: review of sterilization and seal strength records related to work order 3393199 did not identified any deviations or non-conformities that may be associated with the reported device.Sterilization process was successfully completed, and seal strength test results were found to be acceptable.Other records reviewed: environmental monitoring results for nov 2019, and bioburden monitoring results for nov 2019.Review of work order 3393199 and the event code "infection" did not identify any ncs or capa associated with this information.
Event or Problem Description
Healthcare professional reported right side exposure and infection.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
• MDR Report Key: 11476357
• Report Number: 9617229-2021-03773
• Device Sequence Number: 17063553
• Product Code: FTR
• UDI-Device Identifier: 10888628030343
• UDI-Public: 10888628030343
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 10/27/2024
• Device Model Number: SCX-525
• Device Catalogue Number: SCX-525
• Device Lot Number: 3393199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/30/2021
• 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