PHASIX ST 1200011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-11 for PHASIX ST 1200011 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

MAUDE Entry Details

Report Number1213643-2019-09864
MDR Report Key9179615
Report SourceCONSUMER
Date Received2019-10-11
Date of Report2019-10-09
Date Mfgr Received2019-09-23
Date Added to Maude2019-10-11
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 ContactLAURA SUNDBERG
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone4018258462
Manufacturer G1BARD SHANNON LIMITED 3005636544
Manufacturer StreetSAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7
Manufacturer CityHUMACAO PR 00791
Manufacturer CountryUS
Manufacturer Postal Code00791
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePHASIX ST
Generic NameSURGICAL MESH
Product CodeOWT
Date Received2019-10-11
Model NumberNA
Catalog Number1200011
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Manufacturer Address100 CROSSINGS BLVD. WARWICK RI 02886 US 02886


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.