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

Model Number	115-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side rupture.Healthcare professional later reported "inner portion folding," and "fluid collection" device has been explanted.
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The event of 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.Reason for reoperation: rupture and seroma.
Event or Problem Description
Patient reported right side rupture.Healthcare professional reported inner portion folding, fluid collection, and later reported seroma(late).Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified the device was broken shell, flat creases and missing shell.A weight test of the device was verified and the device underweight.A microscopic analysis was performed which identified broken sharp.A dimension measurement in the shell was performed which identify the thickness within specification.Creases/folding of implant condition that was indicated in the complaint was observed, nevertheless it is considered non-related to the manufacturing process, since the device was received out of their primary packaging and is an explanted device.Based on the device analysis the final assessment is: one sharp edge broken in the side posterior assessed as unidentified (tear) opening.Missing shell assessed as inconclusive.Creases/folding of implant condition was observed, nevertheless is not related to the manufacturing process.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13237951
• Report Number: 9617229-2021-60227
• Device Sequence Number: 19970367
• Product Code: FTR
• UDI-Device Identifier: 10888628002302
• UDI-Public: 10888628002302
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 01/22/2023
• Device Model Number: 115-150
• Device Catalogue Number: 115-150
• Device Lot Number: 3170528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female