MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 415CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number MSZ-F415

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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.Device labeling: the natrelle¿ silicone sizer is not intended as an implantable device.Prior to surgery, the surgeon should be familiar with all information provided by the manufacturer of the breast implant to be used.

Event Description

Patient reported unknown side sizer remains implanted.

Event Description

Patient reported unknown side sizer remains implanted.

• Brand Name: NATRELLE INSPIRA FULLPROF 415CC SIZER US
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7960840
• MDR Text Key: 123536266
• Report Number: 9617229-2018-07706
• Device Sequence Number: 1
• Product Code: MRD
• UDI-Device Identifier: 10888628009332
• UDI-Public: 10888628009332
• Combination Product (y/n): N
• PMA/PMN Number: K831566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Catalogue Number: MSZ-F415
• Device Lot Number: 3173112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention