MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 335CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number MSZ-F335

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

Healthcare professional reported "the sizer exploded".This record is for an unknown side.The surgery was completed with a backup device.The device was not implanted.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Photo analysis.Visual analysis of the photographs identified: rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.It is not possible to determine the lot number or catalog through the photos provided.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture.

• Brand Name: NATRELLE INSPIRA FULLPROF 335CC SIZER US
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16907399
• MDR Text Key: 314976982
• Report Number: 9617229-2023-07987
• Device Sequence Number: 1
• Product Code: MRD
• UDI-Device Identifier: 10888628009295
• UDI-Public: 10888628009295
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSZ-F335
• Device Catalogue Number: MSZ-F335
• Device Lot Number: 3662910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 51 KG