SPOT 9F SUCTION TUBE RETRACTOR 292908109

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-13 for SPOT 9F SUCTION TUBE RETRACTOR 292908109 manufactured by Depuy Spine Inc.

MAUDE Entry Details

Report Number1526439-2019-52071
MDR Report Key9036200
Date Received2019-09-13
Date of Report2019-08-19
Date Mfgr Received2019-10-14
Device Manufacturer Date2018-02-15
Date Added to Maude2019-09-13
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1DEPUY SPINE INC
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPOT 9F SUCTION TUBE RETRACTOR
Generic NameCATHETER AND TIP, SUCTION
Product CodeJOL
Date Received2019-09-13
Returned To Mfg2019-08-23
Catalog Number292908109
Lot NumberER172704
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SPINE INC
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-13

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