URODYNAMICS CATHETER 020207

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2018-08-07 for URODYNAMICS CATHETER 020207 manufactured by Cook Inc.

Event Text Entries

[116272918] Occupation: non-healthcare professional. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[116272919] It was reported, prior to opening the sterile package of the urodynamics catheter, a "hair like" material was observed inside the package. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-02353
MDR Report Key7758010
Report SourceDISTRIBUTOR,FOREIGN,OTHER,USE
Date Received2018-08-07
Date of Report2018-09-21
Date of Event2018-07-30
Date Mfgr Received2018-09-20
Device Manufacturer Date2018-01-16
Date Added to Maude2018-08-07
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. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameURODYNAMICS CATHETER
Generic NameFAP CYTOMETRIC GAS (CARBON DIOXIDE
Product CodeFAP
Date Received2018-08-07
Returned To Mfg2018-09-04
Catalog Number020207
Lot Number8513243
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-07

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