ORALPAK 5ML COLS ADAP16 BLS 990573

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-03-12 for ORALPAK 5ML COLS ADAP16 BLS 990573 manufactured by Becton Dickinson Ind. Cirurgicas Ltda.

MAUDE Entry Details

Report Number3003916417-2020-00081
MDR Report Key9824759
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2020-03-12
Date of Report2020-02-24
Date of Event2020-02-21
Date Mfgr Received2020-02-21
Device Manufacturer Date2018-06-27
Date Added to Maude2020-03-12
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 ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652341
Manufacturer G1BECTON DICKINSON IND. CIRURGICAS LTDA
Manufacturer Street550 RUA CYRO CORREIA PEREIRA
Manufacturer CityCURITIBA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORALPAK 5ML COLS ADAP16 BLS
Generic NameORALPAK
Product CodeKYX
Date Received2020-03-12
Catalog Number990573
Lot Number8178540
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON IND. CIRURGICAS LTDA
Manufacturer Address550 RUA CYRO CORREIA PEREIRA CURITIBA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-12

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