3/16"X12' SURGICAL TUBING 0036560

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-09 for 3/16"X12' SURGICAL TUBING 0036560 manufactured by Consolidated Medical Equipment.

MAUDE Entry Details

Report Number3007305485-2019-00453
MDR Report Key9570075
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-01-09
Date of Report2020-02-25
Date Mfgr Received2020-02-24
Device Manufacturer Date2019-02-08
Date Added to Maude2020-01-09
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 ContactMELANIE LANNON
Manufacturer Street11311 CONCEPT BOULEVARD
Manufacturer CityLARGO, FL FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995209
Manufacturer G1CONSOLIDATED MEDICAL EQUIPMENT
Manufacturer StreetALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA
Manufacturer City31136
Manufacturer CountryMX
Manufacturer Postal Code31136
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3/16"X12' SURGICAL TUBING
Generic NameSURGICAL TUBING
Product CodeBYY
Date Received2020-01-09
Returned To Mfg2020-02-07
Catalog Number0036560
Lot Number201902085
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCONSOLIDATED MEDICAL EQUIPMENT
Manufacturer AddressALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA 31136 MX 31136


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-09

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