MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 285CC SIZER (US); SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number MSZ-X285

Device Problem Material Rupture (1546)

Patient Problems Failure of Implant (1924); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Cont.H.6.Health effect f2201 biopsy.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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.

Event Description

Healthcare professional reported a left side exchange due to concerns with the product.Later, healthcare professional reported pain, lump/nodule, capsular contracture baker grade ii, and rupture against the device.Device has been explanted and replaced.

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of necrosis is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: necrosis.

Event Description

Healthcare professional additionally reported necrosis.

• Brand Name: NATRELLE INSPIRA X-FULL 285CC 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: 17175196
• MDR Text Key: 317628569
• Report Number: 9617229-2023-10356
• Device Sequence Number: 1
• Product Code: MRD
• UDI-Device Identifier: 10888628009462
• UDI-Public: 10888628009462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSZ-X285
• Device Catalogue Number: MSZ-X285
• Device Lot Number: 3494141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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
• Patient Weight: 52 KG