PAD, ALCOHOL, DEVICE DISINFECTANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for PAD, ALCOHOL, DEVICE DISINFECTANT manufactured by Health Care Technology.

MAUDE Entry Details

Report Number9117150
MDR Report Key9117150
Date Received2019-09-25
Date of Report2019-08-01
Date of Event2019-08-01
Report Date2019-08-01
Date Reported to FDA2019-08-01
Date Reported to Mfgr2019-09-25
Date Added to Maude2019-09-25
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 OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePAD, ALCOHOL, DEVICE DISINFECTANT
Product CodeLKB
Date Received2019-09-25
Lot Number190744430
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHEALTH CARE TECHNOLOGY
Manufacturer Address200 BUTTERFIELD DRIVE ASHLAND MA 01721 US 01721


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-25

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