400 ML COMP EVAC 1/8" PVC W/TROCAR 3,2MM 10FR PVC 00250000010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-05 for 400 ML COMP EVAC 1/8" PVC W/TROCAR 3,2MM 10FR PVC 00250000010 manufactured by Zimmer Surgical, Inc..

MAUDE Entry Details

Report Number0001526350-2019-00970
MDR Report Key9278815
Report SourceUSER FACILITY
Date Received2019-11-05
Date of Report2019-11-05
Date of Event2019-08-22
Date Mfgr Received2019-10-10
Date Added to Maude2019-11-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER SURGICAL, INC.
Manufacturer Street200 WEST OHIO AVENUE
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal Code44622
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand Name400 ML COMP EVAC 1/8" PVC W/TROCAR 3,2MM 10FR PVC
Generic NameAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Product CodeGCY
Date Received2019-11-05
Catalog Number00250000010
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER SURGICAL, INC.
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US 44622


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-05

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