MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FP 325G RE-STER SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number N-SZRF325

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.It is not possible to fully investigate or confirm the alleged event as the product was discarded and is not available for return to allergan for analysis.Device labeling addresses the reported event as follows: how to open sterile product package: prior to use, keep the sizer covered in the inner package, to prevent contact with airborne and surgical field particulate contaminants.Product examination prior to use: prior to use, examine the re-sterilizable sizer for any evidence of damage or particulate contamination.Do not use any re-sterilizable sizer that may appear to have leaks, nicks or rupture.Do not use damaged or contaminated re-sterilizable sizers.Do not use re-sterilizable sizers that have been damaged or deformed during previous surgical operations.

Event Description

Healthcare professional reported "upon immediately opening" a reusable sizer they noticed "a small dark debris on surface of implant." the "particle" was removed easily and the sizer was "irrigated & used.".

• Brand Name: NATRELLE INSPIRA FP 325G RE-STER SIZER
• 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: 6694910
• MDR Text Key: 79745723
• Report Number: 9617229-2017-00197
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K831566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2021
• Device Catalogue Number: N-SZRF325
• Device Lot Number: 2982039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other