RENOVA'S PEEK PROSTHESIS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-20 for RENOVA'S PEEK PROSTHESIS * manufactured by *.

Event Text Entries

[4334085] All i can say on this is that it just was all of a sudden. I got up feeling that way. Enclosed is the form i filled out to try and find out if the procedure the dr used on my neck surgery was ever supposed to be used for neck surgery and what it has in it since i have had such agony since then. It may be helpful to me, my symptoms are horrible to deal with 24 hours a day. My upper torso feels like it is on fire, burns all the time, i am so hot, hot, hot then if i try and cool off by some means, i can get just as cold as i was hot. When i saw this dr for the last time, he said, here, this will let you know what i used and handed me the exfuse sheet and on back the infuse. I have done lots of research on these and can only find the enclosed sheet on exfuse used for dental work. This is all i have as of this date. I would appreciate any and all the info you can give me to help me get some relief. Thank you.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5035176
• MDR Report Key: 3697956
• Date Received: 2014-03-20
• Date of Event: 2013-09-17
• Date Added to Maude: 2014-03-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: RENOVA'S PEEK PROSTHESIS
• Generic Name: RENOVA'S PEEK PROSTHESIS
• Product Code: ODP
• Date Received: 2014-03-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: EXFUSE
• Generic Name: EXFUSE
• Product Code: MBP
• Date Received: 2014-03-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: HANS BIOMED CORP.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-20