PURSTRING INSTRUMENT 215 020240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-08 for PURSTRING INSTRUMENT 215 020240 manufactured by Covidien Lp Llc North Haven.

MAUDE Entry Details

Report Number1219930-2019-03964
MDR Report Key8767710
Date Received2019-07-08
Date of Report2019-07-08
Date of Event2019-05-30
Date Mfgr Received2019-06-18
Date Added to Maude2019-07-08
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 ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN LP LLC NORTH HAVEN
Manufacturer Street195 MCDERMOTT RD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal Code06473
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePURSTRING INSTRUMENT 215
Product CodeGDJ
Date Received2019-07-08
Model Number020240
Catalog Number020240
Lot Number157-5
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP LLC NORTH HAVEN
Manufacturer Address195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-08

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