MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	120-650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263)
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 lymphoma - alcl - suspected and seroma - late 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: lymphoma - alcl - suspected; seroma - late.
Event or Problem Description
Patient representative provided flow cytometry and surgical pathology results indicating that the patient experienced a late seroma.The results provided the following diagnosis: "abnormal cd30 positive t cells" and "these findings are consistent with non -hodgkin lymphoma in the appropriate clinical and morphologic context.In context of the clinical history, this immunophenotype suggests breast implant -associated anaplastic large cell lymphoma (bia-alcl: provisional entity under the 2016 who classification) but should be correlated in context of the concurrent morphology and possibly other ancillary studies for definitive diagnosis and subclassification." while the marker of cd30+ has been reported, the marker of alk- has not.Affected side is right.The device has been explanted.

• Brand Name: STYLE 120 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: 9890749
• Report Number: 9617229-2020-06602
• Device Sequence Number: 11275332
• Product Code: FTR
• UDI-Device Identifier: 10888628002609
• UDI-Public: 10888628002609
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

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: 11/03/2019
• Device Model Number: 120-650
• Device Catalogue Number: 120-650
• Device Lot Number: 2681271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/27/2020
• 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