PWRD ECH FLEX 45MM 34CM SHAFT PSE45A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for PWRD ECH FLEX 45MM 34CM SHAFT PSE45A manufactured by Ethicon Endo-surgery, Llc..

MAUDE Entry Details

Report Number3005075853-2020-01891
MDR Report Key9908485
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-09
Date of Event2020-03-05
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-11-01
Date Added to Maude2020-03-31
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. KARA DITTY-BOVARD
Manufacturer Street475 CALLE C
Manufacturer CityGUAYNABO 00969
Manufacturer Country*
Manufacturer Postal00969
Manufacturer Phone6107428552
Manufacturer G1ETHICON ENDO-SURGERY, LLC.
Manufacturer Street475 CALLE C
Manufacturer CityGUAYNABO 00969
Manufacturer Country*
Manufacturer Postal Code00969
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePWRD ECH FLEX 45MM 34CM SHAFT
Generic NameSTAPLE, IMPLANTABLE
Product CodeGDW
Date Received2020-03-31
Returned To Mfg2020-03-26
Model NumberPSE45A
Catalog NumberPSE45A
Lot NumberT95333
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO-SURGERY, LLC.
Manufacturer Address475 CALLE C GUAYNABO 00969 * 00969


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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