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-410295
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swollen Lymph Nodes (2093)
Date of Event	12/22/2016
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.Device evaluation: analysis of the returned device identified: creases fold, deformation device, brown particles and weight to the spec.Cloudy and voids in the gel observed after autoclave cycle.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.The event of "enlarged lymph nodes" 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: patient concern with the product, ¿mental pain,¿ ¿enlarged lymph nodes¿ and ¿chronic and severe inflammation, auto inflammatory response.".
Event or Problem Description
Healthcare professional reported left side implant exchange due to patient concern with the product.Patient representative reported patient experienced ¿mental pain,¿ ¿enlarged lymph nodes¿ and ¿chronic and severe inflammation, auto inflammatory response.¿ patient representative also reported patient ¿suffered personal injuries and related damages,¿ ¿urticarial rashes on legs, back and abdomen,¿ ¿severe joint and body aches,¿ ¿fevers,¿ ¿acute liver and kidney injury,¿ ¿chills, night sweats, sore throats,¿ ¿suffering¿ and ¿disfigurement;¿ these events are not related to the device.Device was explanted.This record is for the left side.

• 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: 10992597
• Report Number: 9617229-2020-21894
• Device Sequence Number: 11634678
• Product Code: FTR
• UDI-Device Identifier: 10888628003453
• UDI-Public: 10888628003453
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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

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: 09/20/2019
• Device Model Number: MF-410295
• Device Catalogue Number: MF-410295
• Device Lot Number: 2664085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/11/2020
• 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
• Patient Age: 41 YR