UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for UNKNOWN manufactured by W.l. Gore & Associates.

MAUDE Entry Details

Report Number3003910212-2019-00167
MDR Report Key8692121
Date Received2019-06-12
Date of Report2019-06-12
Date of Event2017-03-13
Date Added to Maude2019-06-12
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 ContactDAMON JACKSON
Manufacturer Street1500 N. 4TH STREET
Manufacturer CityAZ
Manufacturer Phone9285263030
Manufacturer G1MPD APC B/P
Manufacturer StreetP.O. BOX 1408
Manufacturer CityELKTON MD 219221408
Manufacturer CountryUS
Manufacturer Postal Code219221408
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN
Product CodeOWT
Date Received2019-06-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerW.L. GORE & ASSOCIATES
Manufacturer AddressFLAGSTAFF AZ


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-06-12

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