HARH36 HARH36RR

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 2020-03-14 for HARH36 HARH36RR manufactured by Stryker Sustainability Solutions Lakeland.

MAUDE Entry Details

Report Number0001056128-2020-00013
MDR Report Key9832777
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-14
Date of Report2020-03-13
Date of Event2019-12-26
Date Mfgr Received2020-02-20
Device Manufacturer Date2019-03-06
Date Added to Maude2020-03-14
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 ContactMR. MARISSA RICHMOND
Manufacturer Street1810 W. DRAKE DRIVE
Manufacturer CityTEMPE AZ 85283
Manufacturer CountryUS
Manufacturer Postal85283
Manufacturer Phone8888883433
Manufacturer G1STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
Manufacturer Street5300 REGION CT
Manufacturer CityLAKELAND FL 33815
Manufacturer CountryUS
Manufacturer Postal Code33815
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameSCALPEL, ULTRASONIC, REPROCESSED
Product CodeNLQ
Date Received2020-03-14
Returned To Mfg2020-01-14
Model NumberHARH36
Catalog NumberHARH36RR
Lot Number9973982
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER SUSTAINABILITY SOLUTIONS LAKELAND
Manufacturer Address5300 REGION CT LAKELAND FL 33815 US 33815


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-14

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