UNK SIZER (RESTERILIZABLE)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-07 for UNK SIZER (RESTERILIZABLE) manufactured by Allergan (costa Rica).

MAUDE Entry Details

Report Number9617229-2019-05952
MDR Report Key8679969
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-07
Date of Report2019-06-07
Date Mfgr Received2019-05-10
Date Added to Maude2019-06-07
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 ContactMRS. MICHELLE BURGESS
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 NameUNK SIZER (RESTERILIZABLE)
Generic NameSIZER, MAMMARY, BREAST IMPLANT VOLUME
Product CodeMRD
Date Received2019-06-07
Catalog NumberUNK SIZER (RESTERILIZABLE)
Lot NumberNI
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. Other; 2. Required No Informationntervention 2019-06-07

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