SIG HP REV 4IN1 CUT BLK SZ2.5 201103001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-21 for SIG HP REV 4IN1 CUT BLK SZ2.5 201103001 manufactured by Depuy Ireland - 9616671.

MAUDE Entry Details

Report Number1818910-2019-110957
MDR Report Key9215362
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-21
Date of Report2019-09-30
Date of Event2019-09-30
Date Mfgr Received2019-11-25
Device Manufacturer Date2013-08-06
Date Added to Maude2019-10-21
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 Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER IN 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIG HP REV 4IN1 CUT BLK SZ2.5
Generic NameKNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Product CodeHTZ
Date Received2019-10-21
Returned To Mfg2019-11-06
Catalog Number201103001
Lot NumberSO2010518
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY IRELAND - 9616671
Manufacturer AddressLOUGHBEG RINGASKIDDY CO. CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-21

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