PHASIX ST UNKAA110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-10-04 for PHASIX ST UNKAA110 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

MAUDE Entry Details

Report Number1213643-2019-09720
MDR Report Key9155918
Report SourceCONSUMER,OTHER
Date Received2019-10-04
Date of Report2019-10-04
Date Mfgr Received2019-09-25
Date Added to Maude2019-10-04
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 ContactTINA STEIN
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone8015652300
Manufacturer G1TEPHA, INC
Manufacturer Street99 HAYDEN AVENUE EAST WING, SUITE 360
Manufacturer CityLEXINGTON MA 02421
Manufacturer CountryUS
Manufacturer Postal Code02421
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePHASIX ST
Generic NameSURGICAL MESH
Product CodeOWT
Date Received2019-10-04
Model NumberNA
Catalog NumberUNKAA110
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 2019-10-04

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