MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 MF RE-STERILIZABLE SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZMF420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2018
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.Device labeling: each sizer is supplied sterile in a sealed, double package.Sterility of the sizer is maintained only if the packages, including the package seals, are intact.Do not use the product if the packages or seals have been damaged.Do not use damaged or contaminated re-sterilizable sizers.
Event or Problem Description
Healthcare professional reported that a resterilizable breast implant sizer "tore as it was being inserted through a 4 cm incision." additional details provided as "only the shell outside the patient broke.The free silicone touched the outside of the patient only.The part of the sizer in the patient was intact and promptly removed." it is unknown if surgery was completed with a backup device.

• Brand Name: STYLE 410 MF RE-STERILIZABLE SIZER
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7237294
• Report Number: 9617229-2018-00384
• Device Sequence Number: 158039
• Product Code: MRD
• UDI-Device Identifier: 10888628004986
• UDI-Public: 10888628004986
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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 Expiration Date: 10/24/2019
• Device Catalogue Number: MSZMF420
• Device Lot Number: 2675500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 02/02/2018
• 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: Other