NEUROPACK DYNJ49357A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for NEUROPACK DYNJ49357A manufactured by Medline Indutries, Inc..

MAUDE Entry Details

Report NumberMW5087080
MDR Report Key8662454
Date Received2019-05-31
Date of Report2019-05-24
Date of Event2019-05-22
Date Added to Maude2019-06-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNEUROPACK
Generic NameNEUROLOGICAL TRAY
Product CodeOJG
Date Received2019-05-31
Model NumberDYNJ49357A
Catalog NumberDYNJ49357A
Lot Number18KBV540
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUTRIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-31

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