PREMIERPRO PLUS 5064

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for PREMIERPRO PLUS 5064 manufactured by Svs Llc.

MAUDE Entry Details

Report Number9165648
MDR Report Key9165648
Date Received2019-10-08
Date of Report2019-09-24
Date of Event2019-09-23
Report Date2019-09-24
Date Reported to FDA2019-09-24
Date Reported to Mfgr2019-10-08
Date Added to Maude2019-10-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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

Brand NamePREMIERPRO PLUS
Generic NamePOWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
Product CodeLZC
Date Received2019-10-08
Model Number5064
Lot NumberMTI04-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSVS LLC
Manufacturer Address14120 BALLANTYNE CORPORATE PL STE 425 CHARLOTTE NC 28277 US 28277


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-08

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