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

Model Number	115-222
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient reported right side "rupture." the device has been explanted and replaced.
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.Clarification to b.5 and h.6: it had not been confirmed that surgery occurred as scheduled on 18nov2022 in previous medwatch submission.
Event or Problem Description
Patient reported right side "rupture." the device has been explanted and replaced.
Event or Problem Description
Patient reported diagnostic findings for right side as "fluid collection", "internal and external capsular rupture", and "a malignant neoplasm of unknown breast".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, b.6, h.6.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.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed a broken sharp assessed as unidentified (tear) opening (shell thickness was within specification).Seroma-late: unable to confirm as it is a medical event not related to the device.Additional observations: crease flat observed in the device.Wear abrasion observed in the device.No further actions are required as the device was implanted.
Event or Problem Description
Patient reported right side "rupture." patient reported diagnostic findings for right side as "fluid collection", "internal and external capsular rupture", and "a malignant neoplasm of unknown breast".The 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15917683
• Report Number: 9617229-2022-22056
• Device Sequence Number: 14574561
• Product Code: FTR
• UDI-Device Identifier: 10888628002340
• UDI-Public: 10888628002340
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2023
• 2 Devices were Involved in the Event: 1 2

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: 01/07/2022
• Device Model Number: 115-222
• Device Catalogue Number: 115-222
• Device Lot Number: 3016565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 12/29/2022; 02/16/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/29/2022; 01/12/2023; 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2017
• 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: 53 YR
• Patient Sex: Female