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

Model Number	778624
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Skin Inflammation (2443)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the patient experienced urticaria with the bard inlay urethral stent.The urticaria was red, raised and itchy skin rash that occurs on the entire body for three weeks and the kidney stent which was placed 2 days before symptoms began.
Event or Problem Description
It was reported that the patient experienced urticaria with the bard inlay ureteral stent.The urticaria was red and experienced itchy skin rash that occurs on the entire body for three weeks and the kidney stent, which was placed 2 days before the symptoms began.It is unknown what medical intervention was given to urticaria.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: BARD INLAY URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10755738
• Report Number: 1018233-2020-20552
• Device Sequence Number: 19097980
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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 Expiration Date: 02/20/2025
• Device Model Number: 778624
• Device Catalogue Number: 778624-BARD
• Device Lot Number: NGER1685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other