MAUDE Adverse Event Report: FRESENIUS USA, INC. FRESENIUS DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008T BLUESTAR

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Erectile Dysfunction (4511)

Event Date 06/14/2023

Event Type  Injury  

Event Description

Started to have severe itching during and after treatment, until i noticed redness in these areas and developed rashes.Also started having ed (erectile dysfunction) problems around the same time.

• Brand Name: FRESENIUS DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA, INC.
• MDR Report Key: 18274529
• MDR Text Key: 329941370
• Report Number: MW5148856
• Device Sequence Number: 1
• 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: 12/01/2023

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?: Yes
• Device Operator: Other
• Device Model Number: 2008T BLUESTAR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, American Indian Or Alaskan Native