OtherIPY
DEROYAL
Received Mar 15, 2013 · Event occurred Mar 5, 2013
Report 3006851902-2013-00002 · MDR key 3011162
Device
Generic name
Ipy - Orthosis, Lumbo-sacral
Manufacturer
Deroyal Intercontinental, S.r.l.Catalog number
157-01
Product problems
- Material Frayed
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
THE MEDICAL FACILITY REPORTED THAT ONE OF CABLE HAS FRAYED CAUSING THE END USER TO STAB OR POKE HER FINGERS.
Additional Manufacturer Narrative
DEROYAL: RETURN OF THE SAMPLE HAS BEEN REQUESTED. THE INVESTIGATION INTO THE ROOT CAUSE OF THIS REPORT HAS NOT BEEN COMPLETED AT THIS TIME.
Remedial action
- Replace