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

Catalog Number	PWMX30
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.No actions can be taken at this time since a root cause was not identified.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: tems needed for application (not included): trimmers or clippers soap and water wipes drying towel start here: wash your hands before and after this procedure.If placing or removing this product on another person, wear gloves.Please read instructions, warnings, precautions, and recommendations entirely before placing the device.Indications for use: the device is intended for non-invasive urine output management, such as urinary incontinence, in users with male anatomy.Contraindications: users with urinary retention.Warnings: do not use on irritated skin.Examples include, but are not limited to, rashes, skin tears, or blisters.Do not cover fresh surgical wounds with the device.Do not use the device with any material or in any position that blocks the vents on the front of the device or does not allow for airflow through the device.Examples include, but are not limited to, tight clothing or briefs.To avoid potential skin injury, never pull the device directly away from the user.Always peel in the direction from head to foot.Stop use if an allergic reaction occurs.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state, and federal laws and regulations.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.Recommendations: wash hands thoroughly before device placement.Ensure the device remains connected after turning the user, monitoring for pulling and tension on the device.Remove the device prior to walking.Check device placement and user¿s skin at least every 2 hours.Refer to the purewicktm urine collection system ifu for instructions on suction tubing replacement.Purewicktm urine collection system setup 1.Please consult the purewicktm urine collection system instructions for use as needed.Confirm the purewicktm urine collection system, collection canister, and tubing are set up correctly.Turn the unit on, using the on/off switch.Note: ensure all connections are air-tight and check for possible cracks, leaks, kinks, or blockages.2.Securely connect the drainage fitting of the purewicktm male external catheter to the open end of the collector tubing on the purewicktm urine collection system.Placement of purewicktm male external catheter 3.Trim or clip the pubic hair to ensure the product securely adheres to the skin.Check the skin and do not use if there is irritation or breakdown.Clean the penis and the skin around the base of the penis with soap and water or soap and water wipes.Dry skin prior to positioning the device.Note: moisture or soap residue on skin will weaken the adhesive.4.Position the device, aligning drainage fitting towards the feet of the user.Slide the opening of the device over the penis until close to, but not touching, the skin around the base of the penis.Center penis within the opening.Do not place scrotum inside the device.Remove the bottom adhesive peeloff and press the device against the skin below the base of the penis.Remove the top adhesive peeloff and press the device against the skin above the base of the penis.Ensure device has fully adhered around the base of the penis by pressing down on the adhesive.Removal of purewicktm male external catheter 5.Gently lift the top edge of the adhesive base off the skin.In a slow, downward peeling motion, remove the device.If necessary, use a warm, wet cloth or pad to help loosen adhesive.Warning: to avoid potential skin injury, never pull the device directly away from the user.Always peel in the direction from head to foot.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state, and federal laws and regulations.When to replace purewicktm male external catheter 6.Replace the device at least every 24 hours or if soiled with feces, blood, or semen.Wall suction this product is compatible with wall suction in hospital-like settings.If using this set-up, connect the canister to wall suction and set to a minimum of 40 mmhg continuous suction.Always use the minimum amount of suction necessary.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 customer just bought the purewick urine collection system, and they used the system, and it shut off and battery did not kick in.Patient sat in urine and caregiver woke up to the patient screaming because the urine had burnt their skin.They had to flush the male wick with water to cool off the skin.Patient had pain and skin became red due to urine contact, which caregiver claimed it occurred due to machine stopping suctioning.They did not want to pull wick off and replace it because they were so expensive.Representative confirmed with purewick supervisors that the battery should kick in like a generator when unit goes down and sent out new power cord in case a short in cord and made sure it was plugged directly into wall outlet.Per additional information received via liberator on 29oct2024, stated that it looks like wicks are the issue not the unit and the patient was reacting the that the wick.The patient was non-verbal and the patient was screaming on saturday after using the wick.The urine was backed up in the wick and the caregiver turned the purewick off and back on and it pulled the urine to the canister, after they removed the wick and realized the patient's skin was red and stated that the medication they take might cause their urine to be acidic but they thought the reaction was caused because the urine sat on the skin too long.Per liberator via phone on (b)(6) 2024, it was reported that the patient could not use the system at all and wants the money back.Urine was too acidic and when using the male wicks even though it was suctioning properly patient was raw on top of the penis and underneath the penis, stopped using until patient was healed and then started using again and 2 days in a row, patient was raw and on second day now patient was bleeding.No medical intervention was reported.Per liberator via phone on (b)(6) 2024, it was reported that they were inquiring about whether to use wipes to clean the skin prior to applying the wicks.They stated that they were told to do so by the hospital staff and no to do so by the troubleshooting team.They also stated that they believed this was the cause of the wicks leaking sometimes because of the misinformation that they received.They also mentioned that the patient visited the hospital due redness in their private area and was prescribed a topical cream for treatment.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER
• Common Device Name: PUREWICK MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21091893
• Report Number: 1018233-2024-08597
• Device Sequence Number: 14562541
• Product Code: NZU
• UDI-Device Identifier: 00801741226465
• UDI-Public: (01)00801741226465
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/19/2024

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?: 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: 12/18/2024
• Initial Report FDA Received Date: 01/07/2025
• 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