SKATER INTRODUCER SYSTEM 651506300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-04 for SKATER INTRODUCER SYSTEM 651506300 manufactured by Argon Medical Devices Inc..

Event Text Entries

[185004749] The sample device is indicated as available for evaluation. However, as of the date of this report the device has not yet been returned. A follow-up report will be provided by 4/3/2020.
Patient Sequence No: 1, Text Type: N, H10


[185004750] During placement of a drainage catheter, the distal coil of the 0. 018? Guidewire suspected strip off the core.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1625425-2020-00202
MDR Report Key9788709
Report SourceDISTRIBUTOR
Date Received2020-03-04
Date of Report2020-02-20
Date of Event2020-01-16
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-04
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 ContactMS. GAIL SMITH
Manufacturer Street1445 FLAT CREEK ROAD
Manufacturer CityATHENS TX 75751
Manufacturer CountryUS
Manufacturer Postal75751
Manufacturer Phone2144368995
Manufacturer G1ARGON MEDICAL DEVICES INC.
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSKATER INTRODUCER SYSTEM
Generic NameSKATER INTRODUCER
Product CodeGCB
Date Received2020-03-04
Catalog Number651506300
Lot Number11271397
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerARGON MEDICAL DEVICES INC.
Manufacturer Address1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751

Device Sequence Number: 101

Brand NameACETAMINOPHEN 500MG
Product Code---
Date Received2020-03-04
Device Sequence No101
Device Event Key0
ManufacturerMANUFACTURE / COMPOUNDER NAME


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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