PREMIERPRO PLUS 5063

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-23 for PREMIERPRO PLUS 5063 manufactured by Svs Llc.

MAUDE Entry Details

Report Number8926207
MDR Report Key8926207
Date Received2019-08-23
Date of Report2019-08-01
Date of Event2019-07-31
Report Date2019-08-01
Date Reported to FDA2019-08-01
Date Reported to Mfgr2019-08-23
Date Added to Maude2019-08-23
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 NamePREMIERPRO PLUS
Generic NamePOWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
Product CodeLZC
Date Received2019-08-23
Model Number5063
Catalog Number5063
Lot NumberMTH12-16
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSVS LLC
Manufacturer Address14120 BALLANTYNE CORPORATE PLACE, SUITE 425 CHARLOTTE NC 28277 US 28277


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-23

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