Ogos 2021 : Urgent Field Safety Notice 2021-001 : Duoderm CGF & Extra-Thin Dressings - Open seal where packaging layers are not sealed together completely, leaving partial or fully open seal after manufacturing.
Urgent Field Safety Notice 2021-001 : Duoderm CGF & Extra-Thin Dressings - Open seal where packaging layers are not sealed together completely, leaving partial or fully open seal after manufacturing.
Affected Medical Device :
DUODERM EXTRA THIN CGF DRESSING
DUODERM™ CGF™ CONTROL GEL FORMULA DRESSING
MDA Reference Number : MDA/FCA/2021-P119
MDA Registration Number :
GD37834215117
GD319161024618
Decription : Open seal where packaging layers are not sealed together completely, leaving partial or fully open seal after manufacturing.
Local Establishment Contact Detail :
Norazwa Azmi
RA & QA Specialist -Regulatory, South East Asia
ConvaTec Malaysia Sdn Bhd
3A-3, Level 3A, Block A, Dataran PHB, Saujana Resort, Seksyen U2, 40150 Shah Alam, Selangor, Malaysia
Office: (60) 3 7844 0817
Email : norazwa.azmi@com
