HARH36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for HARH36 manufactured by Stryker Sustainability Solutions, Inc..

MAUDE Entry Details

Report Number9145052
MDR Report Key9145052
Date Received2019-10-02
Date of Report2019-09-13
Date of Event2019-07-24
Report Date2019-09-13
Date Reported to FDA2019-09-13
Date Reported to Mfgr2019-10-02
Date Added to Maude2019-10-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameSCALPEL, ULTRASONIC, REPROCESSED
Product CodeNLQ
Date Received2019-10-02
Catalog NumberHARH36
Lot Number10337065
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER SUSTAINABILITY SOLUTIONS, INC.
Manufacturer Address1810 W. DRAKE DR. TEMPE AZ 85283 US 85283


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-02

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