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 : kenna@nyprax.com

 

 A copy of FSN.