VERITAS

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 2020-03-09 for VERITAS manufactured by Baxter Healthcare Corporation.

Event Text Entries

[183908156] Date of event: (b)(6) 2014 to (b)(6) 2016. Elder, e. ? Veritas in immediate implant-based breast reconstruction is associated with higher complications compared with tiloop?. Plast reconstr surg glob open 2019;7: e2533; doi: 10. 1097/ gox. 0000000000002533; published online 31 december 2019. ) should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[183908157] It was reported that 36 patients experienced post-operative events after implant based breast reconstruction surgeries were performed using veritas over a three-year period. It was reported 19 patients experienced seroma, six patients experienced implant rotation, seven patients experienced localized breast pocket infections and four patients experienced wound breakdowns. It was reported the events required surgical or medical interventions (antibiotics, not further specified). No further detail was provided regarding if hospitalization was required or the patient? S outcome. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-01282
MDR Report Key9806475
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-09
Date of Report2020-03-09
Date Mfgr Received2020-02-14
Date Added to Maude2020-03-09
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 Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1SYNOVIS SURGICAL INNOVATIONS
Manufacturer Street2575 UNIVERSITY AVE W
Manufacturer CitySAINT PAUL MN 55114
Manufacturer CountryUS
Manufacturer Postal Code55114
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERITAS
Generic NameMESH, SURGICAL
Product CodeFTM
Date Received2020-03-09
Model NumberNA
Catalog NumberNI
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-09

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