UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for UNKNOWN manufactured by William Cook Europe.

Event Text Entries

[185667338] Manufacturer ref# (b)(4). Catalog# is unknown but referred to as cook celect platinum filter. Occupation: non-healthcare professional. Pma/510(k) k171712. It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
Patient Sequence No: 1, Text Type: N, H10


[185667339] Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2018. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002808486-2020-00375
MDR Report Key9902227
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-23
Date Added to Maude2020-03-31
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. THOMAS HESSNER KIRK
Manufacturer StreetSANDET 6
Manufacturer CityBJAEVERSKOV 4632
Manufacturer G1WILLIAM COOK EUROPE
Manufacturer StreetSANDET 6
Manufacturer CityBJAEVERSKOV 4632
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Product CodeDTK
Date Received2020-03-31
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWILLIAM COOK EUROPE
Manufacturer AddressSANDET 6 BJAEVERSKOV 4632 DA 4632


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-03-31

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