HCSU4525

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-21 for HCSU4525 manufactured by Medline Industries Inc..

MAUDE Entry Details

Report Number1417592-2019-00137
MDR Report Key8915216
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-08-21
Date of Report2019-08-21
Date of Event2019-05-20
Date Mfgr Received2019-07-24
Date Added to Maude2019-08-21
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 ContactBERMON PUNZALAN
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameTUBING,OXYGEN,CRUSH RES,25',CLEAR,UC
Product CodeBYX
Date Received2019-08-21
Catalog NumberHCSU4525
Lot Number49118100006
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-08-21

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