MAUDE Adverse Event Report: UNKNOWN URINARY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 03/13/2020

Event Type  Injury  

Event Description

Reporter of adverse event: patient.Summary of adverse event: hospitalized - urinary catheter was not working.Date of occurrence: (b)(6) 2020.Seriousness of event: hospitalization initial or prolonged.Md aware and drug therapy continues unchanged.Reported to (b)(6) by: patient/caregiver.

• Brand Name: URINARY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10189653
• MDR Text Key: 196474908
• Report Number: MW5095191
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR