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

Model Number	120-550
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Lymphoma (3263)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In response to fda report number mw5090950.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 lymphoma-alcl-suspected is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The reason for reoperation: suspected alcl, rupture, pain, and "voluntary recall".Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.These are known potential adverse events addressed in the product labeling.
Event or Problem Description
Patient reported left side rupture, pain and swelling.Healthcare professional reported removal "due to voluntary recall (asymptomatic patient)".Patient reported via regulatory agency, "diagnosed with bia alcl." pathological markers have not been received.Device remains implanted.
Additional Manufacturer Narrative
Date of alcl diagnosis: "(b)(6) 2019.".
Event or Problem Description
Patient representative also reported patient ¿suffered personal injuries and related damages,¿ this event is not related to the device.Device was explanted.
Additional Manufacturer Narrative
In response to fda report number mw5093263.
Event or Problem Description
Healthcare professional reported, via regulatory agency "implant-associated anaplastic large call lymphoma of left breast.".

• 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: 9362881
• Report Number: 9617229-2019-19304
• Device Sequence Number: 14005694
• Product Code: FTR
• UDI-Device Identifier: 10888628002586
• UDI-Public: 10888628002586
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: P020056
• 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): 12/11/2020

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: 04/09/2020
• Device Model Number: 120-550
• Device Catalogue Number: 120-550
• Device Lot Number: 2737694
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 03/12/2020; 11/13/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 04/10/2020; 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: 38 YR