MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA MODPROF 310CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number MSZ-M310

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/20/2017

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.Device labeling addresses the reported event as follows: each sizer is supplied sterile in a sealed, double package.Sterility of the sizer is maintained only if the packages, including the package seals, are intact.Do not use the product if the packages or seals have been damaged.Do not use damaged or contaminated re-sterilizable sizers.

Event Description

Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it".The device was washed and used.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Lab analysis results: visual analysis of the returned device identified: no unusual conditions and no particles as described in the original report.Visual analysis also identified weight to the spec and bubbles observed in the gel after the autoclave disinfection cycle.Additional analysis was performed and no particulates were observed.A microscopic analysis was performed which identified the device to be intact and functional.Based on the device analysis the final assessment is: no issues found related with the manufacturing process and no particles on the device were observed.The device was found to be intact and functional.

Event Description

Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it".The device was washed and used.

• Brand Name: NATRELLE INSPIRA MODPROF 310CC 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: 6718050
• MDR Text Key: 80277002
• Report Number: 9617229-2017-00207
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Catalogue Number: MSZ-M310
• Device Lot Number: 3033263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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