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

Model Number PWFX30

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2023

Event Type  Injury  

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 after a few days the patient became sore.The patient stated that it hurts they about two or three days, the patient was red and raw from their thighs up.Patient stated that they tried antibiotics, creams, and lotions.Patient stated that it had been three weeks and they thought that they had a yeast infection.The patient had been using this product for less than 90 days.

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".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warnings: discontinue use if an allergic reaction occurs.To avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewick¿ female external catheter, experiencing skin irritation or breakdown at the site.Recommendations: properly placing the purewick¿ female external catheter snugly between the labia and gluteus holds the purewick¿ female external catheter in place for most patients.Mesh underwear may be useful for securing the purewick¿ female external catheter for some patients.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 purewick¿ female external catheter remains in the correct position after turning the patient.Remove the purewick¿ female external catheter prior to ambulation." 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 became sore after a few days.The patient stated that it hurts for about two or three days.The patient was red and raw from their thighs up.They tried antibiotics, creams, and lotions.It had been three weeks and patient thought that they had a yeast infection.The patient had been using this product for less than 90 days.

• 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: 16312056
• MDR Text Key: 308941227
• Report Number: 1018233-2023-00605
• 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: 06/08/2023

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: 01/18/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/09/2023
• 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