UNKNOWN

Description of Event or Problem

(B)(4) HEALTHCARE IS THOUGHT TO BE THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CANE (B)(4). HOWEVER, ACCORDING TO THE CAREGIVER, THE ONLY IDENTIFYING MARKS ON THE CANE ARE "MADE IN (B)(6)" . IT IS TO BE NOTED THAT ALL IMPORTED (B)(4) CANES ARE "MADE IN (B)(6)". WE HAVE ISSUED A LABEL FOT THE RETURN OF THE DEVICE TO CONFIRM IF IT IS A (B)(4) AND DETERMINE ROOT CAUSE. WE ARE FILING THIS MDR IN AN OVERABUNDANCE OF CAUTION. WE DO NOT BELIEVE THE DEVICE IS A (B)(4). THE END-USER REPORTED THAT THE CANE BROKE IN TWO AT THE ADJUSTMENT BUTTON WHILE IN USE. HIS ARM WAS SCRATCHED BY THE JAGGED PART OF THE BROKEN CANE. HE WAS TAKEN TO THE HOSPITAL WHERE HE GOT STITCHES. THE LACERATION HEALED WELL.