Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RENOVA'S PEEK PROSTHESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RENOVA'S PEEK PROSTHESIS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burning Sensation (2146); Hot Flashes/Flushes (2153)
Event Date 09/17/2013
Event Type  Injury  
Event Description
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RENOVA'S PEEK PROSTHESIS
Type of Device
RENOVA'S PEEK PROSTHESIS
MDR Report Key3697956
MDR Text Key4334085
Report NumberMW5035176
Device Sequence Number1
Product Code ODP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/20/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was the Report Sent to FDA? No
Patient Sequence Number1
Treatment
SPIRONOLACTONE, 25MG, 1/2 TO 1 TABLET EVERY OTHER,; VERELAN P.M., 100MG, 1 IN A.M. AND 1 IN P.M.,; ARMOUR THYROID, 90MG, 1 AN HOUR BEFORE BREASFAST; MORNING BY MOUTH; ANACIN, 400MG, ONCE A DAY; NORCO 5-325MG TABLET, 1 TABLET EVERY 6 HRS,; OR AS NEEDED FOR PAIN
Patient Age87 YR
Patient Weight91
-
-