UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-21 for UNKNOWN manufactured by Cook Endoscopy.

MAUDE Entry Details

Report Number1037905-2019-00620
MDR Report Key9215718
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-21
Date of Report2019-09-24
Date Mfgr Received2019-10-21
Date Added to Maude2019-10-21
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. SCOTTIE FARIOLE
Manufacturer Street4900 BETHANIA STATION RD
Manufacturer CityWINSTON-SALEM NC 27105
Manufacturer CountryUS
Manufacturer Postal27105
Manufacturer Phone3367440157
Manufacturer G1COOK ENDOSCOPY
Manufacturer Street4900 BETHANIA STATION RD
Manufacturer CityWINSTON-SALEM NC 27105
Manufacturer CountryUS
Manufacturer Postal Code27105
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NamePTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
Product CodePTS
Date Received2019-10-21
Returned To Mfg2019-10-02
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK ENDOSCOPY
Manufacturer Address4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-21

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