LATEX FOLEY CATHETER UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-11 for LATEX FOLEY CATHETER UNK manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[186415109] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186415110] It was reported that there was an issue with the foley catheter upon removal. The complainant reported that it took 9 attempts to remove the catheter and when they finally removed it, there was bleeding noted. The catheter was reportedly observed to have 'rolled' on itself in the balloon area upon removal. The complainant noted that the associates cut the tip off the catheter to be able to share what was experienced. No medical intervention was reported. The associates reportedly used another catheter to help troubleshoot, and experienced the same issue with the rolling.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01750
MDR Report Key9820072
Report SourceOTHER,USER FACILITY
Date Received2020-03-11
Date of Report2020-03-11
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-11
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 ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLATEX FOLEY CATHETER
Generic NameFOLEY CATHETER
Product CodeEZC
Date Received2020-03-11
Returned To Mfg2020-03-11
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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