MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE

Device Problem Insufficient Information (3190)

Patient Problem Headache (1880)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Neither the phoenix machine nor the disposables were inspected.

• Brand Name: CARTRIDGE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS S.A. DE C.V.; tijuana ; MX
• Manufacturer Contact: ramon ruiz ; blvd pacifico no. 10014; parque industrial pacificao; tijuana ; MX ; 645124212
• MDR Report Key: 4649488
• MDR Text Key: 5678379
• Report Number: 8030638-2015-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1