SURG PATXRAY 1/4X1/4-200 801399

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 2019-08-30 for SURG PATXRAY 1/4X1/4-200 801399 manufactured by Raynham.

MAUDE Entry Details

Report Number1226348-2019-00386
MDR Report Key8950168
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-30
Date of Report2019-08-28
Date of Event2019-08-08
Date Mfgr Received2019-08-28
Date Added to Maude2019-08-30
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. KIMBERLY SHELLY
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 NameSURG PATXRAY 1/4X1/4-200
Generic NameSURGICAL PATTIES
Product CodeHBA
Date Received2019-08-30
Catalog Number801399
Lot NumberHJ0631
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2019-08-30

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