UROMAX ULTRA KIT M0062251210 225-121

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-23 for UROMAX ULTRA KIT M0062251210 225-121 manufactured by Boston Scientific Corporation.

Event Text Entries

[146063138] (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[146063139] It was reported to boston scientific corporation that a uromax ultra ureteral dilatation balloon was used in the ureter during a uteroscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, it was noted that the balloon ruptured during inflation. The procedure was completed with this device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-02678
MDR Report Key8637930
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-23
Date of Report2019-05-23
Date of Event2019-05-06
Date Mfgr Received2019-05-06
Device Manufacturer Date2018-11-17
Date Added to Maude2019-05-23
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC IRELAND LIMITED
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUROMAX ULTRA KIT
Generic NameDILATOR, CATHETER, URETERAL
Product CodeKOE
Date Received2019-05-23
Model NumberM0062251210
Catalog Number225-121
Lot Number0022954753
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-23

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