MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE FRESENIUS DIALYSIS EQUIPMENT

Device Problem Insufficient Information (3190)

Patient Problem Hepatitis (1897)

Event Date 12/08/2017

Event Type  Injury  

Event Description

I have been attending dialysis at (b)(6) since 2014.

• Brand Name: FRESENIUS DIALYSIS EQUIPMENT
• Type of Device: FRESENIUS DIALYSIS EQUIPMENT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE
• MDR Report Key: 7142186
• MDR Text Key: 95737873
• Report Number: MW5074189
• Device Sequence Number: 0
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 34 YR
• Patient Weight: 54