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

Model Number PWFX30

Device Problem Biocompatibility (2886)

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to "material surface is rough, abrasive or uncomfortable ".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: "replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewick female external catheter.Discontinue use if an allergic reaction occurs.".

Event Description

It was reported that the patient experienced irritation from the purewick female external catheter used in the hospital as well as little swelling while in the icu.The patient stated that they removed the purewick female external catheter and took breaks from using it.Also stated that they were constantly cleaning patients and had stopped using purewick altogether.No medical intervention was reported.Per customer via phone on 17dec2021, it was stated that the customer developed a rash and rawness with hospital purewick system.The doctor prescribed an antibiotic save, but the name of the medication was unknown.The customer did not need purewick at home.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13172635
• MDR Text Key: 283296499
• Report Number: 1018233-2022-00004
• 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
• Report Date: 01/04/2022

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: 12/17/2021
• Initial Date FDA Received: 01/05/2022
• 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