MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	MF-410525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/25/2018
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 event of infection (unknown onset) 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: infection, heat sensation.
Event or Problem Description
Patient¿s representative reported for left side, the patient suffered "infection", "chronic pain", "rashes", "itching", "swelling", "heat sensation", and "pain prior to explant procedure¿.Patient representative additionally reported non-device related events of "anxiety (generalized)", "chronic insomnia", "significant weight loss", "chronic gastrointestinal reflux", "chronic headaches", and "depression".The device has been replaced.
Event or Problem Description
Patient¿s representative reported for left side, the patient suffered "infection", "chronic pain", "rashes", "itching", "swelling", "heat sensation", and "pain prior to explant procedure¿.Patient representative additionally reported non-device related events of "anxiety (generalized)", "chronic insomnia", "significant weight loss", "chronic gastrointestinal reflux", "chronic headaches", and "depression".The device has been replaced.
Additional Manufacturer Narrative
Further investigation results: with the information collected during the investigation, there is enough evidence to support that device was manufactured under controlled conditions in accordance with allergan procedures.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.One additional complaint was noted for devices sterilized under the same sterilization run.However, it is unlikely that the events related to the reported infection are associated to the sterilization methods utilized.The terminal sterilization cycle used by allergan was developed and validated to achieve a high level of sterility assurance.The sterilization cycle has been validated to assure that the chance of a non-sterile device is less than one in a million.Given the fact that the cause of the infection cannot be specifically associated to the manufacturing process, and there is not an adverse trend for this type of event no corrective action is deemed necessary at this time.

• Brand Name: STYLE 410 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
• 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: 12549987
• Report Number: 9617229-2021-52642
• Device Sequence Number: 3323038
• Product Code: FTR
• UDI-Device Identifier: 10888628003507
• UDI-Public: 10888628003507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 03/30/2020
• Device Model Number: MF-410525
• Device Catalogue Number: MF-410525
• Device Lot Number: 2731354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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: 59 YR
• Patient Sex: Female