TREASURE COAST CATH LAB PACK DYNJ45157A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-08 for TREASURE COAST CATH LAB PACK DYNJ45157A manufactured by Medline Industries, Inc..

MAUDE Entry Details

Report Number8873281
MDR Report Key8873281
Date Received2019-08-08
Date of Report2019-08-01
Date of Event2019-07-30
Report Date2019-08-01
Date Reported to FDA2019-08-01
Date Reported to Mfgr2019-08-08
Date Added to Maude2019-08-08
Event Key0
Report Source CodeUser Facility 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 Report3

Device Details

Brand NameTREASURE COAST CATH LAB PACK
Generic NameCARDIAC CATHETERIZATION KIT
Product CodeOES
Date Received2019-08-08
Model NumberDYNJ45157A
Catalog NumberDYNJ45157A
Lot Number19BB0971
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer Address1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-08

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