INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT N-TRF450

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 2020-03-31 for INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT N-TRF450 manufactured by Allergan (costa Rica).

Event Text Entries

[186199456] 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. 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: rupture. Device evaluation: visual analysis of the returned device identified: underweight, black particles in the gel/ surface of the shell and broken shell. A microscopic analysis was performed which identify a sharp edge opening assessed as unidentified tear opening. A dimension measurement in the shell was performed which identify the thickness within specification. Based on the device analysis the final assessment is: a sharp opening posterior side assessed as an unidentified (tear) opening.
Patient Sequence No: 1, Text Type: N, H10


[186199457] Healthcare professional reported a left side rupture. The device has been explanted and replaced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617229-2020-02489
MDR Report Key9908285
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2019-12-24
Device Manufacturer Date2013-09-11
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 Professional3
Initial Report to FDA3
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 NameINSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Generic NamePROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Product CodeFTR
Date Received2020-03-31
Returned To Mfg2020-03-04
Catalog NumberN-TRF450
Lot Number2501911
Device Expiration Date2018-09-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2020-03-31

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