NON21438

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 2020-01-15 for NON21438 manufactured by Medline Industries Inc..

MAUDE Entry Details

Report Number1417592-2019-00235
MDR Report Key9591506
Report SourceUSER FACILITY
Date Received2020-01-15
Date of Report2020-01-15
Date of Event2019-12-01
Date Mfgr Received2019-12-24
Date Added to Maude2020-01-15
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 ContactNIGEL VILCHES
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 600932753
Manufacturer CountryUS
Manufacturer Postal600932753
Manufacturer Phone2249311458
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameGAUZE,SPONGE,8"X4",24PLY,XRAY,STRL,LF
Product CodeGDY
Date Received2020-01-15
Catalog NumberNON21438
Lot Number6051812067
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-15

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