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); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684); Skin Inflammation/ Irritation (4545)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter's facility name: (b)(6) hospital.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, where symptomatic treatment including anti-inflammatory and analgesic measures was administered.
Additional Manufacturer Narrative
The initial reporter's facility name: (b)(6).The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction- b, f, h.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 (b)(6) 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 cause may be due to the patient's own ureteral stricture, urinary tract infection, or significant irritation from the stent material.The patient returned to the hospital for follow-up, where symptomatic treatment including anti-inflammatory and analgesic measures was administered.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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.
Event or Problem Description
It was reported that, the patient underwent transurethral ureteroscopy with holmium laser lithotripsy and ureteral stent placement at (b)(6) 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 cause may be due to the patient's own ureteral stricture, urinary tract infection, or significant irritation from the stent material.The patient returned to the hospital for follow-up, where symptomatic treatment including anti-inflammatory and analgesic measures was administered.

• 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23779616
• Report Number: 1018233-2025-11047
• Device Sequence Number: 9934016
• Product Code: FAD
• UDI-Device Identifier: 00801741014833
• UDI-Public: (01)00801741014833(11)241204(17)290913(10)NGJY0165
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 05/08/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/16/2025; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown