MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 10 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	10-450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.The event of late 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.Reasons for reoperation: rupture and seroma-late.These are a known potential adverse events addressed in the product labeling.
Event or Problem Description
Patient reported right side "lump".Patient additionally reported right side "rupture" and "large fluid accumulation." device remains implanted.

• Brand Name: STYLE 10 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: 9382693
• Report Number: 9617229-2019-15139
• Device Sequence Number: 14005312
• Product Code: FTR
• UDI-Device Identifier: 10888628001299
• UDI-Public: 10888628001299
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: 05/22/2021
• Device Catalogue Number: 10-450
• Device Lot Number: 2928913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 11/27/2019
• 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