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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 FX RE-STERILIZABLE SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME
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ALLERGAN (COSTA RICA) STYLE 410 FX RE-STERILIZABLE SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME Back to Search Results
Catalog Number MSZFX775
Medical Device Problem Code Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code Failure of Implant (1924)
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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
 
Event or Problem Description
Healthcare provider reported right side ¿doctor left sizers in a patient thinking they were implants.¿ device has been explanted.
 
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Brand Name
STYLE 410 FX 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 Key8403385
Report Number9617229-2019-01609
Device Sequence Number1922748
Product Code MRD
UDI-Device Identifier10888628005365
UDI-Public10888628005365
Combination Product (Y/N)N
Initial Reporter StateIL
PMA/510(K) Number
K831566
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
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 Date11/01/2020
Device Catalogue NumberMSZFX775
Device Lot Number2839946
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2019
Initial Report FDA Received Date03/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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