MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 525CC SIZER (US); SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number MSZ-X525

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

In response to fda report number mw5088309.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.Reason for reoperation: "sizer accidentally left in patient instead of implant.".

Event Description

Hospital patient safety representative reported "sizer accidentally left in patient instead of implant" on an unknown side.Device status is unknown.

• Brand Name: NATRELLE INSPIRA X-FULL 525CC 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: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8949749
• MDR Text Key: 156108146
• Report Number: 9617229-2019-13310
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MSZ-X525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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