MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 PureWick Male

Catalog Number	PWM030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient began using purewick around (b)(6) while hospitalized at the (b)(6) hospital.He was being treated for a pressure ulcer and a urinary tract infection.After being discharged, he continued to use purewick at home, and a visiting nurse came almost every day to assist him.Today, the care manager in charge contacted us to say that, about three weeks after discharge, the patient was rushed to the hospital last night due to a suspected urinary tract infection.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).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: 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: PureWick Male
• Common Device Name: PureWick
• 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 ; +1(770)784-6100
• MDR Report Key: 50777736
• Report Number: 1018233-2026-05926
• Device Sequence Number: 10664464
• Product Code: NZU
• UDI-Device Identifier: 00801741219153
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: PWM030
• Device Lot Number: NGKZY601
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Male