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

Model Number PWFX30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Urinary Tract Infection (2120); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 12/06/2022

Event Type  Injury  

Event Description

It was reported that the patient had burning, itching, swelling and hot output.The patient had just cleared up from a vaginal infection when they first received the purewick female external catheter and waited 5 days before using again.They reported reaction started within the 1st week of use of.Patient reported tried fluconazan prescription that they had on hand as they frequently get urinary tract infections and vaginal infections due to their diabetes.The patient reported cleared up & then tried using again which resulted in allergic reaction again.Patient reported really needed purewick female external catheter, it was helping them with their incontinence.The patient previously had flesh eating bacteria & a history of skin allergies.The doctor had to cut infection away, took several prescriptions and took 1.5 years to clear up.Patient reported back on wound care.The patient had been using this product for less than 90 days.As per follow-up via phone on 15dec2022, it was reported that the customer did not seek medical intervention and could not confirm that the wick caused their reaction.The customer stopped using the wicks.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter experiencing skin irritation or breakdown at the site".Warnings: discontinue use if an allergic reaction occurs.Recommendations: ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood.Change suction tubing per hospital protocol or at least every thirty (30) days".To avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.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.H3 other text: the device was not returned.

Event Description

It was reported that the patient had burning, itching, swelling and hot output.The patient had just cleared up from a vaginal infection when they first received the purewick female external catheter and waited 5 days before using again.They reported reaction started within the 1st week of use of.Patient reported tried fluconazan prescription that they had on hand as they frequently get urinary tract infections and vaginal infections due to their diabetes.The patient reported cleared up & then tried using again, which resulted in allergic reaction again.Patient reported really needed purewick female external catheter, it was helping them with their incontinence.The patient previously had flesh eating bacteria & a history of skin allergies.The doctor had to cut the infection away, took several prescriptions, and took 1.5 years to clear up.Patient reported back on wound care.The patient had been using this product for less than 90 days.Per follow-up via phone on 15dec2022, it was reported that the customer did not seek medical intervention and could not confirm that the wick caused their reaction.The customer stopped using the wicks.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER LF HC
• Type of Device: FEMALE 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16052463
• MDR Text Key: 306183092
• Report Number: 1018233-2022-09853
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2024
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Device Lot Number: MYGR1506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female