MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PUREWICK MALE EXTERNAL CATHETER

Catalog Number	PWMX30
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
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.The reported event is addressed within the labeling as it states: precautions: not recommended for users who are agitated, combative, or uncooperative and might remove the device.Have frequent episodes of bowel incontinence without a fecal management system in place.Have skin irritation or breakdown at the site.Do not use barrier creams, lotions, or ointments on the penis or pubic skin around the base of the penis when using the device.These may impede suction or weaken adhesive.Proceed with caution in users who have had recent surgery of the external male anatomy.Always check skin for irritation or breakdown and clean and dry the skin prior to placement of a new device.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.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 a registered nurse spoke to the son who purchased device for his father.His father complained of a burning sensation.On the top part of the male wick, around top vent area.Client had been nearing the 24 hour mark with his wick.It also looked discolored.The son was wondering how pee could get there.Registered nurse clarified due to him unable to hold his penis and direct it downwards sometimes it can move and land somewhere else.Client was also worried about the sweat on his back from laying all night.Registered nurse encouraged to use blue pads underneath and ensuring he is getting turned.It is unclear if troubleshooting was performed.It is unknown if lot or serial number was requested.Per follow up information received via phone on 05mar2026,it was reported he was prescribed antibiotics due to the burning sensation in his penis.It was believed to be an uti.The son also stated that he noticed that urine was pooling in the male wick.I referred him to lms for troubleshooting to make sure that the unit is suctioning properly.He will have his father's caregiver to call.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER
• 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 ; 7707846100
• MDR Report Key: 24758364
• Report Number: 1018233-2026-02147
• Device Sequence Number: 8743449
• Product Code: NZU
• UDI-Device Identifier: 00801741226465
• UDI-Public: (01)00801741226465
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PWMX30
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/01/2026
• 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: Other
• Patient Sex: Male