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

Model Number 778624

Device Problem Biocompatibility (2886)

Patient Problem Skin Inflammation (2443)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event 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.

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.

Event 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.

• Brand Name: BARD INLAY URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10755738
• MDR Text Key: 213679823
• Report Number: 1018233-2020-20552
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 778624
• Device Catalogue Number: 778624-BARD
• Device Lot Number: NGER1685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other