ON AUGUST 29, 2016, THE INITIAL REPORTER WAS CONTACTED THROUGH E-MAIL TO TRY TO GAIN ADDITIONAL INFORMATION SUCH AS IF THE DEVICE IS AVAILABLE FOR REVIEW, THE DEVICE LOT NUMBER, ANY PREVIOUS ISSUES USING THE DEVICE, CONDITION OF THE PATIENT'S SKIN PRIOR TO USE AND THE LENGTH OF THE SCAN. ACCORDING TO THE REPORTER ON BEHALF OF THE HOSPITAL "THE ARMBOARD IS NOT AVAILABLE FOR INSPECTION. THE PACKAGING WAS NOT SAVED SO I DID NOT GET A LOT NUMBER. WE HAVE NOT HAD AN ISSUE IN THE PAST. THE PT HAD MULTIPLE SKIN ISSUES AS I NOTED IN THE REPORT. I AM NOT AWARE OF THE TIME IN THE SCANNER. THE SCAN ITSELF DID MEET CONDITIONS STATED IN THE MRI SAFE WEB SITE." UNFORTUNATELY WITHOUT THE DEVICE OR LOT NUMBER THERE IS NO ANALYSIS THAT WE CAN DO AT DALE MEDICAL TO CONFIRM THE ISSUE. THE DALE 650 HAS BEEN TESTED BY A THIRD PARTY MRI SAFETY LAB AND FOUND TO BE MRI CONDITIONAL AND SAFELY BE USED DURING AN MRI UNDER THE STATED CONDITIONS. IN THE FIVE PLUS YEARS SINCE WE RECEIVED OUR RATING, (B)(4), AND HAVE ZERO CONFIRMED COMPLAINTS OF INJURY RELATED TO USING THE ARMBOARDS DURING AN MRI. THE PATIENT HAD MULTIPLE SKIN ABRASIONS DUE TO TRAUMA FROM A MVA WHICH MAY HAVE BEEN THE ACTUAL CAUSE OF THE BURN THAT WAS FOUND ON THE PATIENT.
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Patient 1
REFERENCE MDR-(B)(4) FILED BY (B)(6). ON 8/29/2016 DALE MEDICAL RECEIVED A COPY OF THE NOTED MDR FROM THE FDA STATING THE NOTED FACILITY REPORTED FOLLOWING A MRI THE PATIENT HAD A BLISTER ON THE BACK OF THE HAND. TEXT IS COPIED FROM MDR RECEIVED FROM THE FDA ON 8/29/2016: "TEENAGE PATIENT NOTED TO HAVE BLISTER ON HIS HAND AFTER MRI. PATIENT STATED THAT WHILE IN THE MRI YESTERDAY, HE FELT HIS HAND BURNING UNDERNEATH THE ARMBOARD SECURING HIS ARTERIAL LINE (DALE BENDABLE ARMBOARD). UPON EXITING THE MRI, HE SAID HE TOLD THE STAFF HIS HAND WAS VERY WARM AND IT WAS ATTRIBUTED TO RECEIVING IV CONTRAST. PT TOOK OFF HIS ARMBOARD UPON RETURN TO THE SURGICAL ICU AND NOTICED A BURN WHICH BLISTERED. THE PATIENT HAD A QUARTER-SIZED INTACT SERIOUS FLUID FILLED BLISTER ON BACK OF HAND. THE PATIENT WAS SEEN BY THE MEDICAL TEAM. THE TEAM UNROOFED THE BLISTER AND COVERED IT WITH A BANDAID. THE ARMBOARD IS LISTED AS MRI CONDITIONAL PRODUCT. THE CONDITIONS FOR USE IN THE MRI WERE MET AS THE EXAM WAS 1.5 T AND WITHIN OTHER SPECIFICATIONS."