3M? RED DOT? MONITORING ELECTRODE WITH 3M? MICROPORE? TAPE BACKING N/A 2239

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-06-21 for 3M? RED DOT? MONITORING ELECTRODE WITH 3M? MICROPORE? TAPE BACKING N/A 2239 manufactured by 3m Health Care.

MAUDE Entry Details

Report Number2110898-2019-00083
MDR Report Key8724368
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-06-21
Date of Report2019-06-21
Date of Event2019-04-25
Date Mfgr Received2019-05-27
Date Added to Maude2019-06-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactDIANNE GIBBS
Manufacturer Street3M CENTER, BUILDING 275-5W-06
Manufacturer CityST. PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal55144
Manufacturer Phone6517379117
Manufacturer G13M CANADA COMPANY
Manufacturer Street400 ROUTE 100
Manufacturer CityMORDEN, R6M 1Z9
Manufacturer CountryCA
Manufacturer Postal CodeR6M 1Z9
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M? RED DOT? MONITORING ELECTRODE WITH 3M? MICROPORE? TAPE BACKING
Generic NameECG ELECTRODE
Product CodeDRX
Date Received2019-06-21
Model NumberN/A
Catalog Number2239
Lot Number2020-01 ZN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-21

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