GOWN, SURGICAL L2 700*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-04 for GOWN, SURGICAL L2 700* manufactured by Novo Health Services, Llc.

MAUDE Entry Details

Report Number1000306225-2020-00001
MDR Report Key9666001
Report SourceUSER FACILITY
Date Received2020-02-04
Date of Report2020-01-30
Date of Event2020-01-14
Date Mfgr Received2020-01-20
Date Added to Maude2020-02-04
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 ContactMS. ZILLERY FORTNER
Manufacturer Street1416 DOGWOOD WAY
Manufacturer CityMEBAN NC 27302
Manufacturer CountryUS
Manufacturer Postal27302
Manufacturer Phone5133986406
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGOWN, SURGICAL L2
Generic NameREUSABLE SURGICAL GOWN
Product CodeFYA
Date Received2020-02-04
Model Number700*
Catalog Number700*
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNOVO HEALTH SERVICES, LLC
Manufacturer Address1416 DOGWOOD WAY MEBANE NC 27302 US 27302


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-04

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