MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 495CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number	SSZ-X495
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007); Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: use error and tyvek or thermoform sticking.
Event or Problem Description
Healthcare professional reported "that the inner thermoform and outer thermoform trays were stuck together on all the sizers that were used for the case.We were still able to use the sizers, but poses a great concern to sterility." device has not been implanted.

• Brand Name: NATRELLE INSPIRA X-FULL 495CC SSZ 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: 16233322
• Report Number: 9617229-2023-00989
• Device Sequence Number: 15114689
• Product Code: MRD
• UDI-Device Identifier: 10888628045880
• UDI-Public: 10888628045880
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SSZ-X495
• Device Catalogue Number: SSZ-X495
• Device Lot Number: 3609964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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: Other
• Patient Sex: Female