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 Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: rupture.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.
Event or Problem Description
Patient reported a right side rupture.Device has been explanted.
Event or Problem Description
Healthcare professional confirmed the event of rupture and exchange due to textured implants.Healthcare professional additionally reported "wrinkling, bruised looking breasts, redness, swelling, big and firm, contracture".Device was discarded after surgery.
Additional Manufacturer Narrative
The event of "capsular contracture" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: capsular contracture, baker grade unknown.

• 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: 9865315
• Report Number: 9617229-2020-04454
• Device Sequence Number: 3183112
• Product Code: FTR
• UDI-Device Identifier: 10888628003491
• UDI-Public: 10888628003491
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2021

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: 11/11/2019
• Device Model Number: MF-410470
• Device Catalogue Number: MF-410470
• Device Lot Number: 2683246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 03/28/2021
• 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 Age: 33 YR