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

Model Number	115-185
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	08/01/2021
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.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.
Event or Problem Description
Healthcare professional reported a right side "rupture." device has been explanted and replaced.
Additional Manufacturer Narrative
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.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: analysis of the returned device identified: broken shell, red particles in the gel and shell, and underweight.A visual and microscopic analysis was performed which identified: sharp broken on posterior, stress marks and crease flat.A dimension measurement in the shell was performed which identify the thickness within specification.Base on the device analysis the final assessment is: a sharp pattern on posterior of broken device assessed as a surgical impact opening, for the stress mark in the shell.
Event or Problem Description
Healthcare professional reported a right side "rupture." healthcare professional later reported "folded wavy multidirectional lines" and "small amount of peri-implant fluid".Device has been explanted and replaced.

• 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: 12917809
• Report Number: 9617229-2021-58189
• Device Sequence Number: 17540178
• Product Code: FTR
• UDI-Device Identifier: 10888628002326
• UDI-Public: 10888628002326
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 05/30/2020
• Device Model Number: 115-185
• Device Catalogue Number: 115-185
• Device Lot Number: 2766779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2015
• 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: 56 YR
• Patient Sex: Female