MAUDE Adverse Event Report: BARD SDN. BHD. EXTERNAL FEMALE CATHETER; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Local Reaction (2035); Fungal Infection (2419)

Event Date 09/02/2022

Event Type  Injury  

Event Description

Bard female external catheter placed by hospital staff while i was an inpatient in progressive care unit.The device caused painful irritation and sensitivity tissue reaction to mucosal tissue causing bleeding; 5 months after hospital discharge i continue to have vaginal and suspected fungal vulvular problems.The saturated catheter does not remove all the urine and causes a bacterial/ fungal growth area.Incapacitated patients become victims of secondary infections.

• Brand Name: EXTERNAL FEMALE CATHETER
• Type of Device: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): BARD SDN. BHD.
• MDR Report Key: 16305384
• MDR Text Key: 308956708
• Report Number: MW5114704
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Treatment: OTC HYDROCORTISONE CREAM
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White