BEAVER? AND EDGEAHEAD SAFETY SIDEPORT MVR KNIFE, 1.15 MM, 45 DEGREES (20G) 378231

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-28 for BEAVER? AND EDGEAHEAD SAFETY SIDEPORT MVR KNIFE, 1.15 MM, 45 DEGREES (20G) 378231 manufactured by Beaver Visitec International, Inc.

MAUDE Entry Details

Report Number1211998-2020-00249
MDR Report Key9893249
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-28
Date of Report2020-03-26
Date of Event2019-04-29
Date Mfgr Received2019-05-06
Device Manufacturer Date2019-02-08
Date Added to Maude2020-03-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMS. ROBIN ROWE
Manufacturer Street500 TOTTEN POND RD 10 CITYPOINT
Manufacturer CityWALTHAM, MA
Manufacturer CountryUS
Manufacturer Phone8065779
Manufacturer G1BEAVER VISITEC INTERNATIONAL, INC.
Manufacturer Street500 TOTTEN POND RD 10 CITYPOINT
Manufacturer CityWALTHAM, MA
Manufacturer CountryUS
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-501-2018
Event Type3
Type of Report3

Device Details

Brand NameBEAVER? AND EDGEAHEAD SAFETY SIDEPORT MVR KNIFE, 1.15 MM, 45 DEGREES (20G)
Generic NameBEAVER? AND EDGEAHEAD SAFETY SIDEPORT MVR KNIFE, 1.15 MM, 45 DEGREES (20G)
Product CodeHNN
Date Received2020-03-28
Returned To Mfg2019-05-08
Catalog Number378231
Lot Number6010668
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBEAVER VISITEC INTERNATIONAL, INC
Manufacturer Address500 TOTTEN POND RD 10 CITYPOINT WALTHAM, MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-28

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