WEBCOL 6818

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for WEBCOL 6818 manufactured by Cardinal Health, Inc..

Event Text Entries

[140893114] Rn opened approximately 18 covidien webcol alcohol preps where the pad was dry. Additionally, the pads to not smell as if they ever contained any isopropyl alcohol.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8482000
MDR Report Key8482000
Date Received2019-04-04
Date of Report2019-03-21
Date of Event2019-03-19
Report Date2019-03-21
Date Reported to FDA2019-03-21
Date Reported to Mfgr2019-04-04
Date Added to Maude2019-04-04
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 NameWEBCOL
Generic NamePAD, ALCOHOL, DEVICE DISINFECTANT
Product CodeLKB
Date Received2019-04-04
Model Number6818
Catalog Number6818
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH, INC.
Manufacturer Address785 FORT MILL HWY. FORT MILL SC 29707 US 29707


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-04

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