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-410470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	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 event of seroma 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: exchange from textured to smooth breast implants due to the patient¿s concern with the product.
Event or Problem Description
Healthcare professional reported "left-side exchange from textured to smooth breast implants due to the patient¿s concern with the product" and "seroma".Device has been explanted.
Event or Problem Description
Healthcare professional reported "left-side exchange from textured to smooth breast implants due to the patient¿s concern with the product" and "seroma".Device has been explanted.
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: overweight, deformation, crease fold and yellow particles in the shell.Voids and cloudy in the gel observed after autoclave cycle.After weighting the device, it is observed that it is overweight, however, a review of the weight reports generated during the manufacturing process is performed and all units were within specification.Therefore, the overweight observed during the additional analysis is not considered a workmanship (see the weight report attached).Base on the device analysis the final assessment is: no issues found related with the manufacturing process.

• 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
• MDR Report Key: 11323182
• Report Number: 9617229-2021-02698
• Device Sequence Number: 3443713
• Product Code: FTR
• UDI-Device Identifier: 10888628003491
• UDI-Public: 10888628003491
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 08/25/2019
• Device Model Number: MF-410470
• Device Catalogue Number: MF-410470
• Device Lot Number: 2656327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/19/2021
• 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 Weight: 51