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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT

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C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT Back to Search Results
Catalog Number 788626
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 03/18/2024
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
 
Event Description
It was reported that after ureteroscopic lithotripsy, an indwelling stent was placed in the renal pelvis ureteral bladder, and the patient reported pain.Purpose of this treatment was to relieve ureteral obstruction and promoted stone expulsion.Symptomatic treatment was required.
 
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Brand Name
BARD® INLAY OPTIMA® URETERAL STENT
Type of Device
URETERAL STENT
Manufacturer (Section D)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key19078389
MDR Text Key339805465
Report Number1018233-2024-01955
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00801741015762
UDI-Public(01)00801741015762
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Type of Report Initial
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number788626
Device Lot NumberNGGZ0186
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2024
Initial Date FDA Received04/10/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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