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 Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: rupture.

Event Description

Healthcare professional reported a right side rupture and use error.Device has been explanted and replaced.

Event Description

Healthcare professional reported a right side rupture and use error.Device has been explanted and replaced.

Manufacturer Narrative

Additional, changed, and/or corrected data: b6, e1, e3, h6.

• 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
• 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: 17861396
• MDR Text Key: 324806640
• Report Number: 9617229-2023-15984
• Device Sequence Number: 1
• Product Code: MRD
• UDI-Device Identifier: 10888628009554
• UDI-Public: 10888628009554
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2022
• Device Catalogue Number: MSZ-X525
• Device Lot Number: 3116323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2017
• 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
• Patient Sex: Female