MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 06/25/2014

Event Type  Injury  

Manufacturer Narrative

This is one event (cerebrovascular) for the same patient involving two separate products.

Event Description

The plaintiff's attorney alleged that the patient experienced a cerebrovascular event on or about (b)(6) 2012 after the use of the product.

• Brand Name: NATURALYTE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; waltham MA
• Manufacturer Contact: corie vazquez ; 920 winter street; waltham, MA 02451-1457 ; 7816999071
• MDR Report Key: 4128196
• MDR Text Key: 19538497
• Report Number: 1225714-2014-12224
• Device Sequence Number: 1
• Product Code: KOP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability