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

Catalog Number	PWM030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	11/24/2025
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.All available udi information is being provided.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 the purewick male external catheters edge of pouch insertion hole caused a pressure injury to the shaft of patient's penis.No medical intervention was reported.
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.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it state: warnings: do not use on irritated or compromised skin.Do not cover fresh surgical wounds with the device.Do not use the device with any material or in any position that does not allow for sufficient airflow.To avoid potential skin injury, never pull the device directly away from the user.Always peel in the direction from head to foot.Discontinue 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.Having frequent episodes of bowel incontinence without a fecal management system in place.Experiencing skin irritation or breakdown at the site.Do not use barrier cream on the penis or public skin around the base of the penis when using the device.Creams may impede suction or weaken adhesive.Proceed with caution in users who have undergone recent surgery of the external urogenital tract, penis, or public area.Always assess skin for compromise and perform perineal care prior to placement of a new device.Recommendations: perform each step with clean technique.Assess product placement and user¿s skin every 2 hours or per hospital protocol.Change suction tubing per hospital protocol or at least every thirty (30) days.The dhr review could not be performed without a lot number.All available udi information is being provided.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 the purewick male external catheters edge of pouch insertion hole caused a pressure injury to the shaft of patient's penis.No medical intervention was reported.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER KIT
• Common Device Name: MALE EXTERNAL CATHETER
• 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 30014 ; 7707846100
• MDR Report Key: 23735147
• Report Number: 1018233-2025-10866
• Device Sequence Number: 10615681
• Product Code: NZU
• UDI-Device Identifier: 00801741219153
• UDI-Public: (01)00801741219153
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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