MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	115-203
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/29/2020
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-late 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: rupture and seroma-late.
Event or Problem Description
Patient reported right side rupture and seroma-late."full bowel" was reported, but is not related to the device.The device has been explanted.
Event or Problem Description
Patient reported right side rupture, seroma-late and inflammation/irritation."full bowel" was reported, but is not related to the device.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.4., h.4.
Event or Problem Description
Patient reported right side rupture, seroma-late and inflammation/irritation."full bowel" was reported, but is not related to the device.The device has been explanted.
Event or Problem Description
Patient reported right side rupture and seroma-late."full bowel" was reported, but is not related to the device.The device has been explanted.

• Brand Name: STYLE 115 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: 10333227
• Report Number: 9617229-2020-12651
• Device Sequence Number: 2233920
• Product Code: FTR
• UDI-Device Identifier: 10888628002333
• UDI-Public: 10888628002333
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2021

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: 11/01/2019
• Device Model Number: 115-203
• Device Catalogue Number: 115-203
• Device Lot Number: 2679134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/31/2020; 10/27/2020; 03/15/2021
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/28/2020; 11/25/2020; 04/12/2021
• 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: 38 YR