PHASIX ST MESH 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 2019-09-19 for PHASIX ST MESH UNKAA110 manufactured by Tepha, Inc.

MAUDE Entry Details

Report Number1213643-2019-09031
MDR Report Key9090175
Report SourceCONSUMER,OTHER
Date Received2019-09-19
Date of Report2019-09-19
Date Mfgr Received2019-08-30
Date Added to Maude2019-09-19
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 ContactJAN LING
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone8015652300
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 MESH
Generic NameSURGICAL MESH
Product CodeOWT
Date Received2019-09-19
Model NumberNA
Catalog NumberUNKAA110
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTEPHA, INC
Manufacturer Address99 HAYDEN AVENUE EAST WING, SUITE 360 LEXINGTON MA 02421 US 02421


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-19

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