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

Catalog Number	PWFX30
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	02/02/2026
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.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 the customer stated that only has burning with the pw wick; refusing to consult doctor.Has burning in clitoris area.Advised could be a uti/yeast infection.Claiming she never has those and will try some meds.No medical intervention was provided.It's unclear if lot number was requested.
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 state: maintenance: replace the purewick¿ female external catheter at least every 8 to12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewick¿ female external catheter.Warnings: to avoid potential skin injury, never push or pull the purewick¿ female external catheter against the skin during placement or removal.Never insert the purewick¿ female external catheter into vagina, anal canal, or other body cavities.Discontinue use if an allergic reaction occurs.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewick¿ female external catheter.Having frequent episodes of bowel incontinence without a fecal management system in place.Experiencing skin irritation or breakdown at the site.Experiencing moderate/heavy menstruation and cannot use a tampon.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: f, h.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 the customer stated that only has burning with the pw wick; refusing to consult doctor.Has burning in clitoris area.Advised could be a uti/yeast infection.Claiming she never has those and will try some meds.No medical intervention was provided.It's unclear if lot number was requested.Per customer via email on 11feb2026 it was reported that all it was, was some irritating and burning at her private after using the pure which for a couple weeks.Now we are just using it for bed time and she's been fine.
Event or Problem Description
It was reported that the customer stated that only has burning with the pw wick; refusing to consult doctor.Has burning in clitoris area.Advised could be a uti/yeast infection.Claiming she never has those and will try some meds.No medical intervention was provided.It's unclear if lot number was requested.Per customer via email on 11feb2026 it was reported that all it was, was some irritating and burning at her private after using the pure which for a couple weeks.Now we are just using it for bed time and she's been fine.
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 state: maintenance: replace the purewick¿ female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewick¿ female external catheter.Warnings: to avoid potential skin injury, never push or pull the purewick¿ female external catheter against the skin during placement or removal.Never insert the purewick¿ female external catheter into vagina, anal canal, or other body cavities.Discontinue use if an allergic reaction occurs.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewick¿ female external catheter.Having frequent episodes of bowel incontinence without a fecal management system in place.Experiencing skin irritation or breakdown at the site.Experiencing moderate/heavy menstruation and cannot use a tampon.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: 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 FEMALE EXTERNAL CATHETER
• Common Device Name: PUREWICK FEMALE 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, GA 30014 ; 7707846100
• MDR Report Key: 24338841
• Report Number: 1018233-2026-00862
• Device Sequence Number: 15891422
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 03/16/2026

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: Lay User/Patient
• Device Catalogue Number: PWFX30
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 03/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/13/2026; 03/17/2026
• 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: Female