MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	15-616
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: device rupture, pulmonary embolism.
Event or Problem Description
Patient reported "rupture" and "pulmonary embolism." patient also reported "kidney disease, joint pain, eczema, weight gain and arthritis".These events were determined not to be device-related.Device remains implanted.This record is for the left side.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: weight to the spec, white particle in the shell, deformation and crease fold.Cloudy was observed after autoclave disinfection process.The unit is not broken.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.Additional, changed, and/or corrected data: b5, b6, d6(b), d9, g1, h3, h6.
Event or Problem Description
Patient reported "rupture".Patient also reported "pulmonary embolism", "kidney disease, joint pain, eczema, weight gain and arthritis".These events were determined not to be device-related.This record is for the left side.The device has been explanted.

• Brand Name: STYLE 15 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 12903356
• Report Number: 9617229-2021-57404
• Device Sequence Number: 19987700
• Product Code: FTR
• UDI-Device Identifier: 10888628001541
• UDI-Public: 10888628001541
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 06/03/2020
• Device Model Number: 15-616
• Device Catalogue Number: 15-616
• Device Lot Number: 2766133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2015
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 104 KG