MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA MODPROF 485CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number MSZ-M485

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 08/03/2018

Event Type  malfunction  

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: re-sterilizable breast implant sizers are intended to be used only by a qualified surgeon.Before proceeding with surgery, the surgeon should inform the patient of the following warnings.Re-sterilizable sizers are temporary devices, and are not intended to be used as a permanent implant.They should only be used for temporary intra-operative placement, to assist the surgeon in permanent implant size selection.

Event Description

Healthcare provider reported left side "sizer was implanted on accident." device remains implanted.

• Brand Name: NATRELLE INSPIRA MODPROF 485CC 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: 8039673
• MDR Text Key: 126178555
• Report Number: 9617229-2018-08836
• Device Sequence Number: 1
• Product Code: MRD
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: MSZ-M485
• Device Lot Number: 3207956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2018
• 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): Other