IDEAL SUTURE SHUTTLE 25 DEGREES RIGHT -G 251002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-09-16 for IDEAL SUTURE SHUTTLE 25 DEGREES RIGHT -G 251002 manufactured by Depuy Mitek Llc Us.

MAUDE Entry Details

Report Number1221934-2019-58329
MDR Report Key9069611
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2019-09-16
Date of Report2018-05-02
Date of Event2018-05-02
Date Mfgr Received2018-05-02
Device Manufacturer Date2014-09-17
Date Added to Maude2019-09-16
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 Phone6013142063
Manufacturer G1DEPUY MITEK LLC US
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 NameIDEAL SUTURE SHUTTLE 25 DEGREES RIGHT -G
Generic NameSUTURE/NEEDLE PASSER, SINGLE-USE
Product CodeHCF
Date Received2019-09-16
Catalog Number251002
Lot Number14M08
Device Expiration Date2019-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-16

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