CODMAN SURG STRP1/2X6-200 801451

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-03 for CODMAN SURG STRP1/2X6-200 801451 manufactured by Raynham.

MAUDE Entry Details

Report Number1226348-2019-00441
MDR Report Key9151444
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-03
Date of Report2019-09-19
Date Mfgr Received2019-10-21
Device Manufacturer Date2018-09-26
Date Added to Maude2019-10-03
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 ContactMRS. VIVIAN NELSON
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer G1RAYNHAM
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCODMAN SURG STRP1/2X6-200
Generic NameSURGICAL STRIPS
Product CodeHBA
Date Received2019-10-03
Catalog Number801451
Lot NumberJ0229D
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRAYNHAM
Manufacturer Address325 PARAMOUNT DRIVE 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-03

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