November 2021 : Reporting of FSCA 022021 - Ossur Miami J Select : Addtional User Instructions & Safety Warnings
Reporting of FSCA 022021 - Ossur Miami J Select : Addtional User Instructions & Safety Warnings
Affected Medical Device : Ossur Spinal Orthosis (Miami J Select)
MDA Reference Number : MDA/FCA/2021-P158
MDA Registration Number : GA3379721-62836
Description :
Due to missing information in the IFU, healthcare professionals and users may be unaware of the potential risks and side effects associated with cervical spine immobilization. This may lead to unintended uses of the device, potentially leading to harm.
Local Establishment Contact Detail :
Bharat Kumar A/L Vrajlal Premchand
Director
Nyprax Bussiness Solutions
No. 37 Jalan Terasek Lima, Bangsar Baru, 59100 Kuala Lumpur
Email : [email protected]
