InjuryNOC

E-THOTIC

Received Mar 17, 2015 · Event occurred Jan 1, 2015

Report 2921578-2015-00008 · MDR key 4664173

Device

Generic name

Splint, Extremity, Non-inflatable, External, Non-sterile, Product Code: Noc

Manufacturer

Fixes 4 Kids

Product problems

Difficult to Open or Close

Patient

Not reported

Pressure Sore/Ulcer

Narrative

Description of Event or Problem

CUSTOMER IS COMPLAINING THAT THEY ARE FOLLOWING THE MANUFACTURER'S RECOMMENDATIONS ON ADJUSTING THE TENSION OF THE E-THOTIC; HOWEVER, BASED UPON THEIR LAST TWO PATIENTS THEY ARE FINDING THE DEVICE IS DIFFICULT TO ADJUST AND ARE HAVING TO REMOVE THE BRACE EARLIER THAN REQUIRED. AS SUCH, THE KEY SURGEON FOR THIS DEVICE HAS STATED, "I AM HOLDING OFF ON FURTHER USE FOR NOW". ADDITIONALLY, THE CUSTOMER IS RETURNING ALL UNUSED E-THOTICS, PIN GUIDES, PIN GUIDE HOLDER AND FIXTURE (101,103, 201,202, & 203). THE SURGEON IS STATING, "MY LAST TWO PATIENTS ENDED UP IN THE ER WITH SWELLING THAT REQUIRED REMOVING THE E-THOTIC EARLY."

Additional Manufacturer Narrative

INITIAL REPORT WAS FILED IN ERROR. DEVICE IS NOT IMPORTED.