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

Model Number PWFX30

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported that the patient had irritation and itchiness.The representative recommended to stop usage of the purewick female external catheters.The patient had been using this product for more than 90 days.No medical intervention was reported.Per complainant on (b)(6) 2022, the patient had itching and irritation, their doctor recommended monistat.It helped with the itching.But the patient was currently not using the device because they were trying to clear the irritation up.

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 due to "inadequate material selection - materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable ".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." the device was not returned.

Event Description

It was reported that the patient had irritation and itchiness.The representative recommended to stop usage of the purewick female external catheters.The patient had been using this product for more than 90 days.No medical intervention was reported.Per complainant on 24june2022, the patient had itching and irritation, their doctor recommended monistat.It helped with the itching.But the patient was currently not using the device because they were trying to clear the irritation up.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14987454
• MDR Text Key: 295701084
• Report Number: 1018233-2022-05343
• 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: 09/26/2022

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: 06/24/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 09/27/2022
• 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