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

Catalog Number	778626
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hematuria (2558); Dysuria (2684)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent transurethral ureteroscopy with holmium laser lithotripsy and ureteral stent placement at beiliu city traditional chinese medicine hospital on (b)(6) 2025 and was subsequently discharged.However, on (b)(6) 2025, the patient experienced mild distending pain in the right flank accompanied by dysuria and hematuria.The patient returned to the hospital for follow-up and received symptomatic treatment including anti-inflammatory and analgesic therapy.The patient has been exposed to harmful substances, blood or body fluids and hospitalization.Solution: administer symptomatic treatment including anti-inflammatory and analgesic medications.Monitor the patient's condition.Replace the ureteral stent if necessary.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections 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.
Event or Problem Description
It was reported that the patient underwent transurethral ureteroscopy with holmium laser lithotripsy and ureteral stent placement at beiliu city traditional chinese medicine hospital on (b)(6) 2025 and was subsequently discharged.However, on (b)(6) 2025, the patient experienced mild distending pain in the right flank accompanied by dysuria and hematuria.The patient returned to the hospital for follow-up and received symptomatic treatment including anti-inflammatory and analgesic therapy.The patient has been exposed to harmful substances, blood or body fluids and hospitalization.Solution: administer symptomatic treatment including anti-inflammatory and analgesic medications.Monitor the patient's condition.Replace the ureteral stent if necessary.
Additional Manufacturer Narrative
The investigation did not reveal any additional findings as the sample was not available to allow for further evaluation.Our team conducted a review of the reported event, with the available information to ensure the ongoing safety and performance of the product.As this investigation has already been performed for a similar complaint, another investigation is not necessary.An investigation has been completed using all information currently available.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.Udi format updated with available product information per gudid.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.

• Brand Name: BARD® INLAY® URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23796756
• Report Number: 1018233-2025-11115
• Device Sequence Number: 10470270
• Product Code: FAD
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 778626
• Device Lot Number: NGJY0165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown