MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 800CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	SSZ-X800
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported "did not peel smoothly, were hard to get sizers out of containers, left part of paper on sterile lids, and lids of outer container shredded and left paper film" device was not implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2; a4; b1; b2; d6a; h1; h6.
Additional 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: tyvek or thermoform sticking.
Event or Problem Description
Healthcare professional reported "did not peel smoothly, were hard to get sizers out of containers, left part of paper on sterile lids, and lids of outer container shredded and left paper film" device was not implanted.

• Brand Name: NATRELLE INSPIRA X-FULL 800CC SSZ US
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 22967827
• Report Number: 9617229-2025-15027
• Device Sequence Number: 21117571
• Product Code: MRD
• UDI-Device Identifier: 10888628045972
• UDI-Public: (01)10888628045972(10)1295502(11)250421(17)300321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SSZ-X800
• Device Lot Number: 1295502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 102 KG