MAUDE Adverse Event Report: Allergan (Costa Rica) Natrelle Inspira ModProf 405cc Sizer US; sizer, mammary, breast implant volume

Catalog Number	MSZ-M405
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported through a sales representative a "hair on the sizer".This record is for an unknown side.The device was not implanted.
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: hair/fiber on implant.

• Brand Name: Natrelle Inspira ModProf 405cc 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; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 25227531
• Report Number: 9617229-2026-09340
• Device Sequence Number: 9973847
• Product Code: MRD
• UDI-Device Identifier: 10888628009134
• UDI-Public: (01)(01)10888628009134
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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-M405
• Device Lot Number: 1355330
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2025
• 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
• Patient Sex: Female