SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL 73-0211

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-25 for SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL 73-0211 manufactured by Southmedic Inc..

MAUDE Entry Details

Report Number8022032-2019-00004
MDR Report Key9750899
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-02-25
Date of Report2020-01-03
Date of Event2019-11-01
Date Mfgr Received2019-12-05
Device Manufacturer Date2019-04-04
Date Added to Maude2020-02-25
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 ContactTISH WHITEHEAD
Manufacturer Street50 ALLIANCE BLVD.
Manufacturer CityBARRIE, ONTARIO LM45K3
Manufacturer CountryCA
Manufacturer PostalLM45K3
Manufacturer G1SOUTHMEDIC INC.
Manufacturer Street50 ALLIANCE BLVD.
Manufacturer CityBARRIE, L4M5K3
Manufacturer CountryCA
Manufacturer Postal CodeL4M5K3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL
Generic NameSCALPEL
Product CodeGES
Date Received2020-02-25
Returned To Mfg2019-12-12
Model Number73-0211
Catalog Number73-0211
Lot Number040419
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSOUTHMEDIC INC.
Manufacturer Address50 ALLIANCE BLVD. BARRIE, L4M5K3 CA L4M5K3


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-25

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