JUSTRIGHT 5MM STAPLER JR-ST25-2.0-6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for JUSTRIGHT 5MM STAPLER JR-ST25-2.0-6 manufactured by Bolder Surgical.

MAUDE Entry Details

Report Number3010377594-2020-00001
MDR Report Key9908220
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-08-22
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. DEBORAH PACHECO
Manufacturer Street331 S. 104TH ST. SUITE 200
Manufacturer CityLOUISVILLE, CO
Manufacturer CountryUS
Manufacturer Phone2877134
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJUSTRIGHT 5MM STAPLER
Generic NameMANUAL SURGICAL INSTRUCMENT FOR GENERAL USE
Product CodeGAG
Date Received2020-03-31
Returned To Mfg2020-03-09
Model NumberJR-ST25-2.0-6
Catalog NumberJR-ST25-2.0-6
Lot Number75HI1221
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOLDER SURGICAL
Manufacturer Address331 S. 104TH ST. SUITE 200 LOUISVILLE, CO US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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