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

Catalog Number	FX-410315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Seroma (2069)
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 reported events of late seroma and infection 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.The reasons for reoperation were implant started getting bigger, shooting pain, infection, mastitis, and late seroma.These are known potential adverse events addressed in the product labeling.
Event or Problem Description
Patient reported "implants started getting bigger," "having shooting pain," "infection," "mastitis," and "fluid on implants." patient was treated with antibiotics for infection.Device has been explanted.Affected side left.
Additional Manufacturer Narrative
Further investigation/dhr summary: review of sterilization and seal strength records related to work order (b)(4) 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.With the information collected during the investigation, there is enough evidence to support that device serial number (b)(4) was manufactured under controlled conditions in accordance with allergan medical 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.
Event or Problem Description
Patient reported "implants started getting bigger," "having shooting pain," "infection," "mastitis," and "fluid on implants." patient was treated with antibiotics for infection.Device has been explanted.This record is for the left side.
Event or Problem Description
Patient was treated with antibiotics three times for infection.Patient representative reported ¿had a nipple discharge which has resolved since second course of antibiotics,¿ and pathology results confirmed "abundant acute inflammation present suggestive of abscess." patient representative also reported patient was ¿constantly fatigued¿ and ¿having memory problems;" these events are not related to the device.
Additional Manufacturer Narrative
Additional, corrected and/or changed data: b.5., b.6., g.3., h.6.The event of abscess is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• 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; CS
• MDR Report Key: 9101306
• Report Number: 9617229-2019-14607
• Device Sequence Number: 2923768
• Product Code: FTR
• UDI-Device Identifier: 10888628002968
• UDI-Public: 10888628002968
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2020

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: 08/28/2020
• Device Catalogue Number: FX-410315
• Device Lot Number: 2811098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 12/17/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/08/2019; 01/16/2020
• 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