inforMED
MalfunctionITW

AIRCAST SP-WALKER, MEDIUM

Received Jul 29, 2019 · Event occurred Jun 26, 2019

Report 9616086-2019-00051 · MDR key 8835893

Device

Generic name

Joint, Ankle, External Brace

Manufacturer

Djo, Llc

Model number

01A-M

Lot number

190113-BB

Product problems

  • Crack
  • Crack

Patient

Not reported

  • Bruise/Contusion
  • Bruise/Contusion

Narrative

Additional Manufacturer Narrative

NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT "JUST BELOW THE HINGED PART OF THE TOP OF THE BOOT (SO NOT ON ANY WEIGHT-BEARING SECTION), THE PLASTIC HAS CRACKED. WHILE IT'S NOT A HUGE CRACK, IT HAS RESULTED IN AN ADDITIONAL INJURY TO ME, BECAUSE THE HINGED PART WAS PRESSING AGAINST MY SHIN, LEAVING A SORE RED SPOT ABOUT THE SIZE OF A $2 COIN, THAT IS EXTREMELY SENSITIVE TO THE TOUCH. IT ALSO RENDERS THE BOOT BASICALLY UNUSABLE - IF I NEEDED TO USE IT AGAIN, I COULD NOT, BECAUSE OF THIS BREAK." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.