BARD? X-FORCE? BALLOON DILATION CATHETER 998606

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-11 for BARD? X-FORCE? BALLOON DILATION CATHETER 998606 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[186722170] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[186722171] It was reported that the x-force dilation catheter balloon burst during installation. The patient was not injured. Per additional information from the ibc via email 09mar2020, there were no missing pieces to the burst balloon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01755
MDR Report Key9820377
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-01-13
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 NameBARD? X-FORCE? BALLOON DILATION CATHETER
Generic NameX-FORCE URETERAL DILATION BALLOON CATHETER KIT
Product CodeEZN
Date Received2020-03-11
Model Number998606
Catalog Number998606
Lot NumberBMCRFM65
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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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