PROCARE MAXTRAX AIR WALKER,L
Received Jun 26, 2019 · Event occurred Oct 12, 2018
Report 9616086-2019-00041 · MDR key 8734882
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
UPON COMPLETION OF AN AUDIT OF THE DJ ORTHOPEDICS (B)(4) FACILITY IN (B)(6); FDA ISSUED A FINDING ON 13 DECEMBER 2018 THAT "PROCEDURES FOR RECEIVING, REVIEWING, AND EVALUATING COMPLAINTS BY A FORMALLY DESIGNATED UNIT HAVE NOT BEEN ADEQUATELY ESTABLISHED." THIS REPORT IS BEING SUBMITTED AS PART OF DJO'S EFFORTS TO ADDRESS THIS FINDING. NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION. NO LOT NUMBER WAS PROVIDED, SO NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. COMPLAINT DATA FOR SIMILAR PRODUCTS AND ISSUES GOING BACK 9 MONTHS HAS BEEN REVIEWED. THE TREND INDICATES THAT REPORTED CUSTOMER COMPLAINTS ARE WITHIN CONTROL.
Description of Event or Problem
IT WAS REPORTED THAT A NEUROPATHIC PATIENT WORE MAXTRAX BOOT AND GOT A HEEL ULCER FROM ANTERIOR STRAP. FURTHER INFORMATION WAS REQUESTED BUT NOT PROVIDED.