CYSTO 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 2019-06-27 for CYSTO PACK DYNJ49344 manufactured by Medline Industries, Inc..

MAUDE Entry Details

Report NumberMW5087685
MDR Report Key8744231
Date Received2019-06-27
Date of Report2019-06-25
Date of Event2019-06-24
Date Added to Maude2019-06-28
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 Sequence Number: 1

Brand NameCYSTO PACK
Generic NameDRAPE, SURGICAL
Product CodeKKX
Date Received2019-06-27
Model NumberDYNJ49344
Catalog NumberDYNJ49344
Lot Number19BBI244
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressNORTHFIELD IL 60093 US 60093

Device Sequence Number: 2

Brand NameCYSTO PACK
Generic NameDRAPE, SURGICAL
Product CodeKKX
Date Received2019-06-27
Model NumberDYNJ49344
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-27

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