MAUDE Adverse Event Report: ALLERGAN, INC. NATRELLE INSPIRA COHESIVE BREAST IMPLANTS; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	SCF-745
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A patient's left breast implant required removal due to infection.Both breasts were implanted 3 months prior at another facility.The removal procedure occurred without complications and the implant is being stored by clinical engineering.

• Brand Name: NATRELLE INSPIRA COHESIVE BREAST IMPLANTS
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN, INC.; 2525 dupont drive; irvine CA 92612
• MDR Report Key: 8288295
• Report Number: 8288295
• Device Sequence Number: 11378417
• Product Code: FTR
• UDI-Device Identifier: 10888628030206
• UDI-Public: (01)10888628030206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2019
• Report Date (Section F): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SCF-745
• Device Catalogue Number: SCF-745
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 86
• Date Report Sent to FDA: 01/11/2019