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

Model Number PWFX30

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Discomfort (2330)

Event Date 11/12/2022

Event Type  Injury  

Event Description

It was reported that the patient used the purewick female external catheter for 5 days and had allergic reaction.The patient experienced rawness after being moved from hospital to assisted living.The customer was not sure if wicks were changed every 8 to 12 hours in hospital and reported canister was not being cleaned between uses.The customer also stated that the patient was prescribed (rx) with cream and it had not cleared up yet.The patient had been using this product for less than 30 days.Per follow up via phone on 17nov2022, it was reported that the customer has returned the purewick and no longer using the device.

Manufacturer Narrative

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

Event Description

It was reported that the patient used the purewick female external catheter for 5 days and had allergic reaction.The patient experienced rawness after being moved from hospital to assisted living.The customer was not sure if wicks were changed every 8 to 12 hours in hospital and reported canister was not being cleaned between uses.The customer also stated that the patient was prescribed (rx) with cream and it had not cleared up yet.The patient had been using this product for less than 30 days.Per follow up via phone on 17nov2022, it was reported that the customer has returned the purewick and no longer using the device.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The 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 lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "discontinue use if an allergic reaction occurs"."replace the purewicktm 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 purewicktm female external catheter"."assess device placement and patient¿s skin at least every 2 hours"."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"."not recommended for patients who are: experiencing skin irritation or breakdown at the site".Correction: g, h11: section a through f - the information provided by bard represents all of 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 bard.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: PUREWICK 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: 15876647
• MDR Text Key: 304424052
• Report Number: 1018233-2022-09014
• 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: 02/08/2023

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 Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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