PROXIS? URETERAL ACCESS SHEATH 231235

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for PROXIS? URETERAL ACCESS SHEATH 231235 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[144097891] 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


[144097892] It was reported that the ureteral access sheath was used during a procedure of calculus removal in calyx. A fibrous foreign material was found in the kidney. Then, the foreign material was removed with an endoscope. The facility requested to confirm if the foreign matter was derived from the ureteral access sheath.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2019-02316
MDR Report Key8579205
Date Received2019-05-03
Date of Report2019-07-01
Date of Event2019-04-09
Date Mfgr Received2019-06-17
Date Added to Maude2019-05-03
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 Report0

Device Details

Brand NamePROXIS? URETERAL ACCESS SHEATH
Generic NameURETERAL ACCESS SHEATH
Product CodeFED
Date Received2019-05-03
Returned To Mfg2019-04-24
Catalog Number231235
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-03

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