Dale Bendable Armboard 650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H84106501), received between Nov 28, 2016 and Nov 28, 2016 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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."

  Patient problems: Injury

  MAUDE report 6129736 ↗