CATALYST 4
Received Dec 20, 2022 · Event occurred Feb 19, 2022
Report 3005905321-2022-00005 · MDR key 16018249
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- Hematoma
- Hematoma
Narrative
Description of Event or Problem
THERAPIST TOLD DEALER THAT USER WAS REACHING FORWARD FOR SOMETHING IN DINING ROOM, AND SAID THAT LEFT CASTER BOTTOM LEFT ECCENTRIC NUT WORKED ITSELF OUT, IT DOES NOT SEEM BROKEN PER DEALER. BOLT WAS BACKED HALF WAY OUT AND THE WASHER AND NUT WAS MISSING WHEN HE RECEIVED THE CHAIR. USER WAS TAKEN TO HOSPITAL AND DIAGNOSED WITH SUBDURAL HEMATOMA. (BUMP ON HEAD) RETURNED LAST NIGHT TO THE FACILITY. IN THE HOSPITAL NOTES PER THERAPIST, IT STATED NEURO SURGERY WAS CONSULTED AND NO PAIN IN HIS BACK, NO DISTRACTING INJURIES. CT WAS NEG FOR INJURY, HE HAS FULL RANGE OF MOTION AND THE CERVICAL COLLAR WAS CLEARED. CT OF THE HEAD SHOWED SMALL SUBDURAL HEMATOMA.
Remedial action
- Replace