MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 560CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-F560
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional 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.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 or Problem Description
Reviewed an email from (b)(6).Forwarding an email received on 18/oct/2023, reported "busted".Device not implanted.

• Brand Name: NATRELLE INSPIRA FULLPROF 560CC SIZER US
• Common Device Name: 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: 18111418
• Report Number: 9617229-2023-18360
• Device Sequence Number: 7863252
• Product Code: MRD
• UDI-Device Identifier: 10888628009370
• UDI-Public: 10888628009370
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MSZ-F560
• Device Lot Number: 1184463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female