GIA PREMIUM 030735L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-22 for GIA PREMIUM 030735L manufactured by Us Surgical Puerto Rico.

MAUDE Entry Details

Report Number2647580-2019-03767
MDR Report Key8810333
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-22
Date of Report2019-07-22
Date of Event2019-07-04
Date Mfgr Received2019-07-04
Device Manufacturer Date2018-11-12
Date Added to Maude2019-07-22
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 ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGIA PREMIUM
Generic NameAPPARATUS, SUTURING, STOMACH AND INTESTINAL
Product CodeFHM
Date Received2019-07-22
Model Number030735L
Catalog Number030735L
Lot NumberP8L1191Y
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-22

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