STYLE 68 SALINE FILLED BREAST IMPLANT 68-270

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-29 for STYLE 68 SALINE FILLED BREAST IMPLANT 68-270 manufactured by Allergan (costa Rica).

MAUDE Entry Details

Report Number9617229-2019-18986
MDR Report Key9391694
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-10-26
Date Mfgr Received2019-11-01
Device Manufacturer Date2015-06-29
Date Added to Maude2019-11-29
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 NameSTYLE 68 SALINE FILLED BREAST IMPLANT
Generic NamePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Product CodeFWM
Date Received2019-11-29
Catalog Number68-270
Lot Number2761278
Device Expiration Date2019-05-29
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 2019-11-29

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