CBC II KIT WITH 3/16IN ROUND PVC WOUND DRAIN 0225426000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-07-26 for CBC II KIT WITH 3/16IN ROUND PVC WOUND DRAIN 0225426000 manufactured by Stryker Instruments-puerto Rico.

MAUDE Entry Details

Report Number0001811755-2019-02574
MDR Report Key8833712
Report SourceUSER FACILITY
Date Received2019-07-26
Date of Report2019-07-26
Date of Event2019-07-08
Date Mfgr Received2019-07-08
Date Added to Maude2019-07-26
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. ZACH BAKER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-PUERTO RICO
Manufacturer StreetLAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2
Manufacturer CityARROYO 00615
Manufacturer Postal Code00615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCBC II KIT WITH 3/16IN ROUND PVC WOUND DRAIN
Generic NameAPPARATUS, AUTOTRANSFUSION
Product CodeCAC
Date Received2019-07-26
Catalog Number0225426000
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-PUERTO RICO
Manufacturer AddressLAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2 ARROYO 00615 00615


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-26

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