STYLE 410 FX RE-STERILIZABLE SIZER MSZFX775

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-08 for STYLE 410 FX RE-STERILIZABLE SIZER MSZFX775 manufactured by Allergan (costa Rica).

Event Text Entries

[138217721] 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.
Patient Sequence No: 1, Text Type: N, H10


[138217722] Healthcare provider reported right side? Doctor left sizers in a patient thinking they were implants.? Device has been explanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617229-2019-01609
MDR Report Key8403385
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-08
Date Mfgr Received2019-02-15
Device Manufacturer Date2015-12-01
Date Added to Maude2019-03-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SUZANNE WOJCIK
Manufacturer Street301 W HOWARD LANE SUITE 100
Manufacturer CityAUSTIN TX 78753
Manufacturer CountryUS
Manufacturer Postal78753
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (COSTA RICA)
Manufacturer Street900 PARKWAY GLOBAL PARK ZONA FRANCA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTYLE 410 FX RE-STERILIZABLE SIZER
Generic NameSIZER, MAMMARY, BREAST IMPLANT VOLUME
Product CodeMRD
Date Received2019-03-08
Catalog NumberMSZFX775
Lot Number2839946
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (COSTA RICA)
Manufacturer Address900 PARKWAY GLOBAL PARK ZONA FRANCA CS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-03-08

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