MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	68-550
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "deflation, pain, staph infections, concerns with the recalled product, breast implant illness implant exchange".This record is for the left -side.Device remains implanted.
Additional Manufacturer Narrative
The event of capsular contracture 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.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: deflation, staph infections.
Event or Problem Description
Patient reported "deflation, pain, staph infections, concerns with the recalled product, breast implant illness implant exchange".This record is for the left -side.Device remains implanted.
Additional Manufacturer Narrative
Further investigation summary: with the information collected during the investigation, there is enough evidence to support that units involved in this work order were manufactured under controlled conditions in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents related to the reported event.Seal strength was successfully completed and results were acceptable.Environmental monitoring results were found to be acceptable, and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.One additional complaint was noted for devices sterilized under sterilization run 30017959.However, it is unlikely that the events related to the reported infection are associated with the sterilization methods utilized.The terminal sterilization cycle used by abbvie was developed and validated to achieve a high level of sterility assurance.The sterilization cycle has been validated to ensure that the chance of a non-sterile device is less than one in a million.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with infection will continue to be monitored and corrective actions will be taken in the future if deemed appropriate given the fact that the cause of the infection cannot be specifically associated with the manufacturing process, and there is not an adverse trend for this type of event, and no er/ ncr(s) were identified during the investigation associated with this lot and the complaint, no corrective action is deemed necessary at this time.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23176418
• Report Number: 9617229-2025-16546
• Device Sequence Number: 8954093
• Product Code: FWM
• UDI-Device Identifier: 10888628000292
• UDI-Public: (01)10888628000292(10)2696997(11)150130(17)181230
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2018
• Device Catalogue Number: 68-550
• Device Lot Number: 2696997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2015
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White