PROXIS? URETERAL ACCESS SHEATH 231235 231035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for PROXIS? URETERAL ACCESS SHEATH 231235 231035 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[117576420] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10


[117576421] It was reported the sheath peeled during insertion and removal of the fiber scope. There were no missing pieces. It was later reported on (b)(6) 2018, that the outside of the tube of the sheath may have peeled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-03606
MDR Report Key7789541
Date Received2018-08-16
Date of Report2019-01-10
Date of Event2018-07-24
Date Mfgr Received2018-12-18
Device Manufacturer Date2017-07-17
Date Added to Maude2018-08-16
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 NamePROXIS ACCESS SHEATH
Product CodeFED
Date Received2018-08-16
Returned To Mfg2018-08-16
Model Number231235
Catalog Number231035
Lot NumberBMBUFM01
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
10 2018-08-16

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