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,consum report with the FDA on 2019-02-19 for UNK SIZER (RESTERILIZABLE) manufactured by Allergan (costa Rica).

Event Text Entries

[136535662] 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


[136535663] Patient reported a rupture on an unknown side. Device was explanted.
Patient Sequence No: 1, Text Type: D, B5


[139912788] Device evaluation: visual analysis of the returned device identified two curved openings. A microscopic analysis was performed which identified two sharp openings. A thickness measurement was not performed because the catalog is unknown. Based on the device analysis the final assessment is: two sharp openings assessed as unidentified tear opening.
Patient Sequence No: 1, Text Type: N, H10


[139912789] Patient reported a rupture on an unknown side. Device was explanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617229-2019-00802
MDR Report Key8351595
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2019-02-19
Date of Report2019-03-25
Date Mfgr Received2019-02-27
Date Added to Maude2019-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 Received2019-02-19
Returned To Mfg2019-02-11
Catalog NumberUNK SIZER (RESTERILIZABLE)
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (COSTA RICA)
Manufacturer Address900 PARKWAY GLOBAL PARK ZONA FRANCA CS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-02-19

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