PE ADULT-PED DRY/ WET LF A-6000-08LF

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 2019-07-02 for PE ADULT-PED DRY/ WET LF A-6000-08LF manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3004365956-2019-00171
MDR Report Key8755120
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-02
Date of Report2019-06-06
Date of Event2019-06-04
Date Mfgr Received2019-09-17
Device Manufacturer Date2018-10-15
Date Added to Maude2019-07-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePE ADULT-PED DRY/ WET LF
Generic NameBOTTLE, COLLECTION, VACUUM
Product CodeKDQ
Date Received2019-07-02
Returned To Mfg2019-08-23
Catalog NumberA-6000-08LF
Lot Number74K1801905
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-02

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