InjuryIQF
LERMAN MINERVA
Received Jul 1, 2013 · Event occurred Jun 18, 2013
Report 3207029 · MDR key 3207029
Device
Generic name
Orthosis, Cervical-thoracic, Rigid
Manufacturer
Trulife, Inc.Model number
A193000SMCatalog number
*
Lot number
*
Product problems
- Insufficient Device Problem Information
Patient
86 YR
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
AN ELDERLY PATIENT WITH C-2 VERTEBRAL BODY FRACTURE IMMOBILIZED IN LERMAN MINERVA BRACE. DESPITE PADDING AND CUSTOM FITTING DEVELOPED STAGE 3 PRESSURE ULCER ON JAW AND STAGE 2 PRESSURE ULCERS ON CLAVICLE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IMMOBILIZATION OF CERVICAL SPINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.