STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT 27-FX135-495

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-03-31 for STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT 27-FX135-495 manufactured by Allergan (costa Rica).

Event Text Entries

[186308833] Allergan did not submit this mdr within 30 days of becoming aware. Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume. Allergan is implementing a plan to address the increased volumes. ? A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Reason for reoperation: capsular contracture, baker grade unknown and gel bleed.
Patient Sequence No: 1, Text Type: N, H10


[186308914] A patient reported they experienced the events of? Recurrent capsular formation with painful symptoms? ,? General malaise? ,? Joint pains? ,? Increase in known allergies? ,? Asia (autoimmune syndrome induced by adjuvants) syndrome? , and? Release of silicone particles? With a style 410 cohesive silicone gel filled breast implant on the left side. Device has been explanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617229-2020-05290
MDR Report Key9908524
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-01-06
Device Manufacturer Date2008-11-14
Date Added to Maude2020-03-31
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 Street12331-A RIATA TRACE PARKWAY BUILDING 3
Manufacturer CityAUSTIN TX 78727
Manufacturer CountryUS
Manufacturer Postal78727
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 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Generic NamePROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Product CodeFTR
Date Received2020-03-31
Catalog Number27-FX135-495
Lot Number1673495
Device Expiration Date2013-11-12
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 2020-03-31

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