BEMIS QUICK FIT 1500CC SUCTION LINER 1504

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-27 for BEMIS QUICK FIT 1500CC SUCTION LINER 1504 manufactured by Bemis De Mexico, Sa De Cv.

MAUDE Entry Details

Report Number3011198121-2019-00003
MDR Report Key9130827
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-09-27
Date of Report2019-09-27
Date of Event2019-09-05
Date Facility Aware2019-09-05
Report Date2019-09-05
Date Reported to Mfgr2019-09-05
Date Mfgr Received2019-09-05
Device Manufacturer Date2019-04-23
Date Added to Maude2019-09-27
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 RODOLFO VILLARREAL
Manufacturer StreetAV TEXAS #200 PARQUE INDUSTRIAL NACIONAL
Manufacturer CityCIENEGA DE FLORES, NUEVO LEON 65550
Manufacturer CountryMX
Manufacturer Postal65550
Manufacturer G1BEMIS DE MEXICO, SA DE CV
Manufacturer StreetAV TEXAS #200 PARQUE INDUSTRIAL NACIONAL
Manufacturer CityCIENEGA DE FLORES, 65550
Manufacturer CountryMX
Manufacturer Postal Code65550
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBEMIS QUICK FIT 1500CC SUCTION LINER
Generic NameSUCTION SYSTEM CANISER LINER
Product CodeGCX
Date Received2019-09-27
Model Number1504
Catalog Number1504
Lot Number179890
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age4 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBEMIS DE MEXICO, SA DE CV
Manufacturer AddressAV TEXAS #200 PARQUE INDUSTRIAL NACIONAL CIENEGA DE FLORES, 65550 MX 65550


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-27

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