THERAPEUTIC BOOT

Description of Event or Problem

PATIENT CALLED TO REPORT A PRODUCT ISSUE AND ADVERSE EVENT INVOLVING A BREG THERAPEUTIC BOOT HE BEGAN WEARING IN EARLY DECEMBER DUE TO A LEFT 5TH METATARSAL FRACTURE. PATIENT STATED HE WAS INSTRUCTED TO WEAR THE BOOT FOR 8 WEEKS AND THAT THE BOOT WAS AMBIDEXTROUS DESIGNED TO BE WORN ON EITHER THE RIGHT OR LEFT FOOT WITH ARCH SUPPORT ON BOTH SIDES. PATIENT STATED DUE TO THE DESIGN, AND THE ARCH SUPPORT BEING ON BOTH SIDES, IT PRESSED UPON HIS 5TH METATARSAL CAUSING HIM TERRIBLE PAIN AND FURTHER SEPARATION THAN WHEN HE BEGAN WEARING THE BOOT. PATIENT SAID AFTER WEARING THE BOOT FOR 4 WEEKS AND MAKING HIS FRACTURE WORSE HE SAW HIS DOCTOR WHO REMOVED THE FOAM ARCH SUPPORT PADDING WITH A SCALPEL ON THE SIDE OF THE BOOT THAT WAS CAUSING PRESSURE AND THE PAIN STOPPED. PATIENT STATED WHILE HE HOPES THE FRACTURE WILL HEAL PROPERLY NOW, HE WAS TOLD HE MAY NEED SURGERY TO CORRECT THE SEPARATION THAT OCCURRED DURING THE FIRST 4 WEEKS OF WEARING THE BOOT DUE TO THE FOAM PADDING.