ENDOPACK DYNJ53271C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-10 for ENDOPACK DYNJ53271C manufactured by Medline Industries, Inc..

MAUDE Entry Details

Report Number8775363
MDR Report Key8775363
Date Received2019-07-10
Date of Report2019-07-05
Date of Event2019-07-03
Report Date2019-07-05
Date Reported to FDA2019-07-05
Date Reported to Mfgr2019-07-10
Date Added to Maude2019-07-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameLAPAROSCOPY KIT
Product CodeFDE
Date Received2019-07-10
Model NumberENDOPACK
Catalog NumberDYNJ53271C
Lot Number19DBP816
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 2019-07-10

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