GALAFLEX CE0408 100035-36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-28 for GALAFLEX CE0408 100035-36 manufactured by Tepha, Inc.

MAUDE Entry Details

Report Number3005670760-2020-00001
MDR Report Key9771948
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-28
Date of Report2020-02-26
Date of Event2020-02-11
Date Mfgr Received2020-02-12
Device Manufacturer Date2019-01-07
Date Added to Maude2020-02-28
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 BARBARA RINALDI
Manufacturer Street99 HAYDEN AVE. SUITE 360
Manufacturer CityLEXINGTON, MA
Manufacturer CountryUS
Manufacturer Phone3251758
Manufacturer G1TEPHA, INC
Manufacturer Street99 HAYDEN AVE
Manufacturer CityLEXINGTON, MA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGALAFLEX
Generic NameSURGICAL MESH
Product CodeOOD
Date Received2020-02-28
Model NumberCE0408
Catalog Number100035-36
Lot Number190008
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTEPHA, INC
Manufacturer Address99 HAYDEN AVE LEXINGTON, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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