MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 700CC SIZER (US); SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-X700
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: capsular contracture, baker grade iii; use error.
Event or Problem Description
Healthcare professional reported left side ¿capsular contracture baker grade iii.¿ additionally, the intended use of this device was not for implantation.The device remains implanted.

• Brand Name: NATRELLE INSPIRA X-FULL 700CC SIZER (US)
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10218969
• Report Number: 9617229-2020-09625
• Device Sequence Number: 19474229
• Product Code: MRD
• UDI-Device Identifier: 10888628009615
• UDI-Public: 10888628009615
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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 Expiration Date: 12/21/2023
• Device Catalogue Number: MSZ-X700
• Device Lot Number: 3301794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR