COTTONY II DACRON, SILKY II, POLYDEK&TEVDEK I OEM UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for COTTONY II DACRON, SILKY II, POLYDEK&TEVDEK I OEM UNKNOWN manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3004365956-2020-00087
MDR Report Key9844784
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-17
Date of Report2020-02-21
Date of Event2019-11-07
Date Mfgr Received2020-02-21
Date Added to Maude2020-03-17
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 ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOTTONY II DACRON, SILKY II, POLYDEK&TEVDEK I
Product CodeGAT
Date Received2020-03-17
Catalog NumberOEM UNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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