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

Catalog Number	SCF-605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	02/28/2022
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.The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: seroma and infection early onset.Fi summary: the review of the documentation associated to the manufacturing process indicates that all devices with work order (b)(4) were released in accordance with allergan procedures, and no anomalies were found in the documents related to the reported event.The device has not been received for analysis in the device analysis laboratory yet.A review of the current risk documents was performed and the event of packaging error (tyvek or thermoform sticking) is a known event, for which manufacturing process controls and inspections are stablished to reduce the incidence of this defect.Considering that there is not an adverse trend for this type of event (only pr# (b)(4) in feb 2021) no additional actions are deemed required at this time.The issues with packaging error (tyvek or thermoform sticking) will continue to be monitored and corrective action taken in the future if deemed appropriate.
Event or Problem Description
Company representative reported "could not get inner sterile plastic out" against device.Healthcare professional reporter later reported infection and seroma.Device explanted and discarded.

• Brand Name: INSPIRA SMOOTH COHESIVE 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 ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 20500462
• Report Number: 9617229-2024-0011581
• Device Sequence Number: 12600837
• Product Code: FTR
• UDI-Device Identifier: 10888628030176
• UDI-Public: 10888628030176
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 09/07/2026
• Device Catalogue Number: SCF-605
• Device Lot Number: 3554339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 10/07/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 75 KG