CYTSO PACK DYNJ49344

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-05 for CYTSO PACK DYNJ49344 manufactured by Medline Industries, Inc..

MAUDE Entry Details

Report NumberMW5087919
MDR Report Key8768378
Date Received2019-07-05
Date of Report2019-07-02
Date of Event2019-07-01
Date Added to Maude2019-07-08
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 NameCYTSO PACK
Generic NameDRAPE, SURGICAL
Product CodeKKX
Date Received2019-07-05
Model NumberDYNJ49344
Catalog NumberDYNJ49344
Lot Number19PBC848
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressNORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-05

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